Recall of Device Recall STAAR Surgical nanoFLEX IOL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Staar Surgical Co..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65558
  • Event Risk Class
    Class 2
  • Event Number
    Z-1746-2013
  • Event Initiated Date
    2013-06-10
  • Event Date Posted
    2013-07-17
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-10-17
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    intraocular lens - Product Code HQL
  • Reason
    Staar surgical company is recalling a limited number of nanoflex cc4204a and afinity cq2015a intraocular lenses due to the potential presence of glass particles in the storage vial.
  • Action
    The firm, STAAR Surgical, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated June 10, 2013 to all the customers that received a limited number of nanoFLEX CC4204A and Afinity CQ2015 Intraocular lenses. The letter described the product, problem and actions to be taken. The customers were instructed to check your inventory; remove any lenses from the attached list; contact STAAR Surgical Customer Service for Returns Goods Authorization Number via phone: 1-800-352-7842; email: customerservice@staar.com; and/or fax: 1-800-952-4923; return listed lenses to STAAR Surgical; complete and return the attached response form by fax to Customer Service at (800) 952-4923, and pass this notice on to all those who need to be aware within your organization or any organization where the devices have been transferred. If you have any questions or concerns regarding the product return, contact STAAR Surgical Customer Service at (800) 352-7842.

Device

  • Model / Serial
    Serial Numbers: B377007 B377125 B377343 B377522 B377622 B377914 B378040 B378215 B377008 B377126 B377347 B377526 B377627 B377915 B378041 B378216 B377009 B377130 B377348 B377531 B377632 B377918 B378042 B378217 B377010 B377131 B377349 B377532 B377635 B377920 B378043 B378218 B377013 B377142 B377350 B377536 B377640 B377921 B378051 B378219 B377016 B377151 B377352 B377538 B377643 B377923 B378053 B378220 B377020 B377153 B377353 B377539 B377650 B377926 B378057 B378222 B377024 B377154 B377354 B377541 B377651 B377936 B378058 B378223 B377025 B377158 B377355 B377542 B377655 B377940 B378059 B378225 B377026 B377161 B377356 B377543 B377660 B377942 B378062 B378227 B377029 B377165 B377357 B377544 B377669 B377943 B378063 B378228 B377030 B377167 B377358 B377548 B377678 B377944 B378065 B378231 B377032 B377168 B377359 B377550 B377681 B377945 B378067 B378234 B377034 B377171 B377360 B377551 B377686 B377946 B378068 B378235 B377035 B377172 B377361 B377552 B377687 B377950 B378070 B378236 B377036 B377255 B377362 B377553 B377689 B377959 B378071 B378239 B377037 B377258 B377363 B377554 B377690 B377960 B378072 B378241 B377038 B377259 B377366 B377555 B377691 B377963 B378075 B378242 B377040 B377262 B377367 B377557 B377692 B377964 B378076 B378248 B377041 B377263 B377368 B377558 B377693 B377971 B378077 B378255 B377042 B377264 B377369 B377559 B377700 B377972 B378081 B378257 B377043 B377267 B377370 B377560 B377706 B377974 B378082 B378258 B377045 B377270 B377371 B377561 B377707 B377975 B378083 B378259 B377049 B377273 B377372 B377562 B377713 B377979 B378086 B378263 B377054 B377276 B377374 B377563 B377718 B377983 B378087 B378264 B377057 B377278 B377376 B377564 B377721 B377988 B378165 B378265 B377061 B377285 B377377 B377567 B377727 B377991 B378171 B378267 B377062 B377288 B377378 B377569 B377730 B377993 B378172 B378268 B377065 B377290 B377383 B377570 B377741 B377998 B378173 B378269 B377068 B377291 B377384 B377571 B377744 B377999 B378175 B378271 B377070 B377297 B377386 B377572 B377745 B378000 B378177 B378274 B377074 B377298 B377388 B377573 B377746 B378002 B378178 B378275 B377081 B377301 B377389 B377575 B377748 B378006 B378179 B378277 B377083 B377305 B377396 B377576 B377756 B378008 B378180 B378282 B377085 B377306 B377397 B377578 B377759 B378019 B378182 B378284 B377087 B377308 B377400 B377579 B377764 B378020 B378186 B378286 B377095 B377314 B377402 B377587 B377765 B378024 B378188 B378291 B377096 B377315 B377409 B377588 B377766 B378027 B378190 B378298 B377099 B377317 B377411 B377594 B377769 B378028 B378192 B378299 B377102 B377319 B377414 B377596 B377774 B378029 B378194 B378302 B377105 B377323 B377415 B377598 B377776 B378030 B378198 B378303 B377106 B377324 B377416 B377599 B377900 B378031 B378199 B378304 B377113 B377332 B377420 B377601 B377901 B378032 B378206 B378306 B377114 B377336 B377421 B377602 B377902 B378034 B378208 B378307 B377118 B377337 B377422 B377603 B377904 B378035 B378209 B378308 B377120 B377338 B377498 B377610 B377906 B378036 B378210 B378311 B377121 B377341 B377511 B377616 B377908 B378038 B378211 B378312 B378314 B378415 B378505 B378597 B378750 B378822 B379221 B379329 B378316 B378416 B378506 B378600 B378755 B378824 B379223 B379331 B378317 B378418 B378507 B378601 B378757 B378825 B379226 B379333 B378319 B378421 B378509 B378605 B378759 B378831 B379228 B379334 B378320 B378425 B378510 B378607 B378760 B378833 B379230 B379335 B378321 B378426 B378511 B378611 B378761 B378834 B379231 B379337 B378322 B378427 B378516 B378612 B378762 B378835 B379232 B379343 B378326 B378428 B378517 B378625 B378763 B378836 B379233 B379345 B378328 B378429 B378518 B378626 B378765 B378838 B379235 B379347 B378331 B378430 B378522 B378628 B378766 B378842 B379236 B379349 B378332 B378431 B378523 B378632 B378767 B378847 B379237 B379354 B378334 B378433 B378526 B378634 B378768 B378848 B379239 B379357 B378337 B378438 B378529 B378639 B378769 B378852 B379240 B379363 B378351 B378441 B378530 B378640 B378770 B378853 B379243 B379365 B378353 B378444 B378531 B378642 B378771 B378854 B379244 B379366 B378365 B378445 B378533 B378646 B378774 B378855 B379245 B379367 B378369 B378446 B378535 B378652 B378776 B378856 B379248 B379368 B378371 B378448 B378537 B378653 B378777 B378857 B379249 B379369 B378372 B378449 B378538 B378655 B378780 B378859 B379253 B379371 B378373 B378452 B378539 B378656 B378781 B378860 B379254 B379372 B378374 B378456 B378540 B378659 B378783 B378861 B379256 B379373 B378375 B378462 B378541 B378660 B378785 B378862 B379258 B379374 B378376 B378466 B378546 B378664 B378786 B378864 B379259 B379375 B378378 B378468 B378547 B378671 B378787 B378865 B379260 B379376 B378380 B378470 B378549 B378674 B378790 B378868 B379261 B379377 B378381 B378472 B378550 B378677 B378791 B378874 B379263 B379378 B378383 B378473 B378553 B378679 B378792 B378875 B379265 B379379 B378384 B378474 B378555 B378680 B378793 B378876 B379266 B379380 B378388 B378480 B378556 B378681 B378794 B378877 B379268 B379381 B378390 B378481 B378557 B378684 B378795 B378884 B379277 B379382 B378391 B378483 B378558 B378690 B378798 B378885 B379279 B379383 B378392 B378485 B378559 B378691 B378799 B378888 B379282 B379384 B378394 B378486 B378560 B378692 B378800 B378894 B379284 B379385 B378395 B378487 B378561 B378701 B378801 B378895 B379288 B379387 B378399 B378488 B378563 B378703 B378802 B378897 B379289 B379388 B378402 B378490 B378565 B378705 B378803 B379197 B379290 B379389 B378403 B378491 B378569 B378712 B378805 B379198 B379291 B379390 B378404 B378492 B378570 B378714 B378808 B379201 B379292 B379391 B378405 B378493 B378571 B378716 B378809 B379202 B379293 B379393 B378406 B378494 B378572 B378727 B378810 B379205 B379296 B379396 B378407 B378496 B378573 B378729 B378811 B379208 B379308 B379397 B378408 B378498 B378574 B378735 B378812 B379211 B379309 B379398 B378410 B378500 B378575 B378737 B378813 B379212 B379311 B379400 B378411 B378501 B378583 B378740 B378814 B379215 B379319 B379404 B378412 B378502 B378586 B378742 B378815 B379216 B379321 B379405 B378413 B378503 B378588 B378746 B378820 B379219 B379324 B379406 B378414 B378504 B378595 B378747 B378821 B379220 B379327 B379407 B379412 B379595 B379750 B379838 B379917 B380009 B380364 B380438 B379413 B379597 B379751 B379839 B379918 B380010 B380365 B380442 B379416 B379599 B379752 B379844 B379919 B380294 B380366 B380459 B379421 B379603 B379753 B379845 B379920 B380297 B380367 B380463 B379427 B379605 B379754 B379847 B379921 B380298 B380370 B380469 B379431 B379606 B379756 B379848 B379922 B380299 B380372 B380471 B379433 B379608 B379757 B379850 B379923 B380300 B380373 B380472 B379434 B379610 B379758 B379852 B379924 B380303 B380375 B380474 B379442 B379615 B379760 B379853 B379925 B380304 B380376 B380475 B379446 B379619 B379761 B379854 B379927 B380305 B380377 B380477 B379454 B379620 B379762 B379855 B379928 B380307 B380378 B380479 B379456 B379621 B379763 B379856 B379929 B380309 B380379 B380480 B379457 B379666 B379764 B379858 B379930 B380316 B380382 B380482 B379458 B379670 B379766 B379860 B379935 B380317 B380384 B380484 B379459 B379672 B379767 B379862 B379939 B380319 B380385 B380485 B379461 B379673 B379768 B379863 B379941 B380321 B380387 B380486 B379462 B379680 B379769 B379865 B379942 B380322 B380388 B380487 B379464 B379682 B379772 B379866 B379945 B380324 B380389 B380492 B379470 B379683 B379775 B379867 B379954 B380325 B380390 B380494 B379471 B379689 B379776 B379868 B379956 B380327 B380391 B380496 B379472 B379690 B379779 B379869 B379961 B380328 B380393 B380499 B379473 B379695 B379781 B379870 B379964 B380329 B380394 B380500 B379475 B379696 B379785 B379872 B379966 B380330 B380395 B380501 B379477 B379697 B379786 B379873 B379968 B380331 B380396 B380504 B379478 B379698 B379789 B379874 B379972 B380332 B380397 B380506 B379480 B379699 B379792 B379875 B379973 B380333 B380398 B380507 B379481 B379700 B379794 B379879 B379974 B380335 B380399 B380510 B379483 B379702 B379796 B379881 B379978 B380337 B380400 B380512 B379484 B379703 B379799 B379884 B379979 B380338 B380401 B380513 B379485 B379711 B379801 B379886 B379982 B380339 B380404 B380515 B379488 B379713 B379802 B379887 B379983 B380340 B380407 B380608 B379537 B379714 B379806 B379889 B379986 B380341 B380409 B380619 B379543 B379715 B379807 B379893 B379987 B380342 B380411 B380620 B379547 B379720 B379814 B379896 B379989 B380343 B380413 B380621 B379548 B379722 B379816 B379897 B379990 B380346 B380414 B380623 B379549 B379725 B379821 B379898 B379991 B380347 B380415 B380624 B379550 B379726 B379822 B379900 B379993 B380348 B380419 B380626 B379559 B379729 B379825 B379901 B379995 B380349 B380420 B380627 B379569 B379730 B379826 B379902 B379996 B380350 B380422 B380628 B379573 B379731 B379827 B379905 B379999 B380353 B380423 B380631 B379576 B379732 B379828 B379906 B380000 B380354 B380425 B380633 B379578 B379737 B379830 B379907 B380001 B380355 B380426 B380635 B379579 B379738 B379831 B379908 B380002 B380357 B380429 B380640 B379581 B379743 B379832 B379911 B380004 B380358 B380431 B380642 B379582 B379746 B379833 B379912 B380005 B380359 B380434 B380643 B379583 B379747 B379835 B379913 B380007 B380360 B380435 B380644 B379586 B379749 B379836 B379914 B380008 B380363 B380437 B380645 B380646 B380834 B380912 B381263 B381355 B381646 B381747 B381855 B380648 B380835 B380913 B381264 B381358 B381650 B381748 B381856 B380651 B380837 B380914 B381265 B381360 B381654 B381749 B381858 B380656 B380838 B380915 B381266 B381361 B381656 B381751 B381862 B380657 B380843 B380917 B381267 B381363 B381657 B381752 B381863 B380659 B380844 B380926 B381268 B381366 B381659 B381756 B381864 B380660 B380846 B380927 B381269 B381369 B381661 B381757 B381865 B380669 B380847 B380928 B381270 B381372 B381663 B381759 B381867 B380672 B380848 B380929 B381274 B381393 B381665 B381760 B381871 B380676 B380853 B380930 B381275 B381419 B381667 B381761 B381872 B380680 B380854 B380936 B381278 B381426 B381668 B381762 B381878 B380682 B380857 B380940 B381280 B381436 B381670 B381763 B381879 B380683 B380858 B380941 B381281 B381437 B381671 B381765 B381881 B380685 B380859 B380942 B381282 B381441 B381672 B381768 B381884 B380687 B380863 B380951 B381283 B381445 B381676 B381769 B381887 B380688 B380866 B380956 B381284 B381451 B381681 B381770 B381890 B380689 B380868 B380957 B381286 B381457 B381682 B381771 B381892 B380695 B380869 B380960 B381288 B381551 B381683 B381773 B381893 B380696 B380870 B380961 B381289 B381552 B381688 B381774 B381894 B380703 B380871 B380968 B381290 B381563 B381701 B381783 B381897 B380704 B380872 B380970 B381291 B381564 B381703 B381785 B381905 B380706 B380874 B380978 B381292 B381568 B381706 B381787 B381910 B380715 B380875 B380979 B381296 B381570 B381707 B381788 B381912 B380727 B380876 B380985 B381297 B381571 B381708 B381789 B381913 B380730 B380877 B380990 B381305 B381572 B381709 B381791 B381914 B380734 B380878 B380991 B381306 B381574 B381710 B381792 B381920 B380735 B380879 B380993 B381308 B381575 B381711 B381793 B381922 B380738 B380880 B380994 B381309 B381577 B381714 B381794 B381924 B380739 B380881 B380996 B381310 B381578 B381715 B381795 B381925 B380742 B380882 B380998 B381311 B381579 B381716 B381802 B381926 B380743 B380885 B381245 B381312 B381580 B381717 B381808 B381928 B380745 B380886 B381246 B381313 B381585 B381718 B381818 B381930 B380748 B380887 B381247 B381316 B381592 B381719 B381827 B381933 B380751 B380888 B381248 B381317 B381593 B381722 B381837 B381934 B380752 B380891 B381249 B381320 B381594 B381723 B381839 B381935 B380753 B380893 B381250 B381323 B381597 B381725 B381841 B381936 B380755 B380894 B381251 B381324 B381603 B381726 B381842 B381937 B380759 B380898 B381252 B381325 B381608 B381727 B381843 B381939 B380761 B380900 B381254 B381326 B381610 B381729 B381845 B381940 B380765 B380902 B381255 B381331 B381612 B381730 B381846 B381943 B380766 B380903 B381256 B381333 B381621 B381731 B381847 B381949 B380767 B380904 B381257 B381335 B381629 B381732 B381848 B381950 B380817 B380906 B381258 B381338 B381633 B381736 B381849 B381953 B380818 B380907 B381259 B381343 B381640 B381738 B381850 B381954 B380828 B380908 B381260 B381345 B381642 B381739 B381852 B381955 B380829 B380909 B381261 B381353 B381643 B381741 B381853 B381958 B380830 B380910 B381262 B381354 B381644 B381742 B381854 B381962 B381963 B382107 B382208 B382335 B382915 B383007 B383082 B383186 B381968 B382115 B382209 B382343 B382920 B383008 B383084 B383188 B381969 B382118 B382210 B382345 B382925 B383009 B383086 B383189 B381975 B382119 B382213 B382346 B382931 B383012 B383087 B383190 B381976 B382120 B382214 B382348 B382933 B383013 B383088 B383191 B381979 B382122 B382217 B382349 B382934 B383015 B383089 B383193 B381980 B382125 B382220 B382353 B382935 B383016 B383091 B383199 B381982 B382126 B382223 B382356 B382936 B383018 B383094 B383201 B381983 B382127 B382224 B382357 B382939 B383019 B383095 B383206 B381984 B382130 B382225 B382359 B382940 B383020 B383096 B383210 B381986 B382131 B382227 B382368 B382944 B383022 B383097 B383211 B381987 B382138 B382229 B382369 B382945 B383025 B383101 B383216 B381991 B382140 B382230 B382373 B382946 B383026 B383102 B383219 B381995 B382141 B382232 B382375 B382947 B383027 B383103 B383227 B381997 B382146 B382235 B382614 B382948 B383029 B383104 B383259 B381999 B382149 B382240 B382858 B382949 B383030 B383105 B383261 B382001 B382151 B382241 B382859 B382950 B383031 B383107 B383263 B382004 B382153 B382242 B382860 B382951 B383032 B383108 B383266 B382009 B382154 B382248 B382861 B382953 B383033 B383111 B383267 B382010 B382158 B382251 B382863 B382954 B383034 B383113 B383271 B382011 B382159 B382252 B382864 B382956 B383036 B383114 B383273 B382012 B382165 B382253 B382866 B382957 B383037 B383115 B383275 B382013 B382167 B382265 B382869 B382960 B383038 B383118 B383280 B382014 B382168 B382268 B382870 B382961 B383040 B383119 B383284 B382015 B382169 B382269 B382871 B382962 B383041 B383122 B383285 B382017 B382172 B382270 B382873 B382963 B383043 B383124 B383286 B382018 B382173 B382278 B382875 B382965 B383044 B383127 B383287 B382020 B382174 B382282 B382878 B382966 B383051 B383135 B383292 B382022 B382175 B382284 B382882 B382968 B383052 B383136 B383297 B382025 B382176 B382286 B382883 B382969 B383053 B383137 B383300 B382026 B382177 B382287 B382884 B382971 B383055 B383138 B383301 B382028 B382178 B382288 B382889 B382972 B383058 B383141 B383302 B382029 B382179 B382290 B382890 B382973 B383059 B383143 B383303 B382030 B382181 B382291 B382892 B382974 B383061 B383144 B383305 B382031 B382182 B382294 B382895 B382975 B383062 B383147 B383309 B382032 B382183 B382295 B382896 B382977 B383063 B383152 B383310 B382033 B382185 B382296 B382898 B382979 B383064 B383153 B383311 B382035 B382187 B382298 B382900 B382983 B383065 B383154 B383312 B382038 B382189 B382300 B382902 B382987 B383067 B383155 B383313 B382040 B382190 B382301 B382904 B382989 B383068 B383162 B383315 B382042 B382191 B382303 B382905 B382990 B383070 B383164 B383316 B382044 B382192 B382310 B382906 B382992 B383071 B383167 B383318 B382045 B382195 B382315 B382907 B382993 B383074 B383168 B383319 B382049 B382196 B382316 B382910 B382995 B383075 B383172 B383320 B382069 B382200 B382317 B382911 B382997 B383077 B383179 B383323 B382079 B382204 B382322 B382912 B382999 B383078 B383183 B383327 B382082 B382205 B382328 B382914 B383006 B383081 B383184 B383328 B383330 B383403 B383584 B383669 B383764 B383870 B384150 B384283 B383331 B383404 B383585 B383672 B383768 B383872 B384151 B384284 B383332 B383406 B383586 B383673 B383782 B383878 B384152 B384285 B383334 B383408 B383587 B383675 B383787 B383891 B384155 B384287 B383335 B383414 B383588 B383676 B383790 B383898 B384156 B384288 B383336 B383415 B383589 B383677 B383791 B383904 B384157 B384289 B383337 B383419 B383592 B383678 B383792 B383905 B384162 B384291 B383342 B383422 B383596 B383682 B383793 B383907 B384163 B384292 B383344 B383423 B383597 B383683 B383795 B383908 B384164 B384296 B383345 B383425 B383598 B383685 B383797 B384103 B384165 B384308 B383347 B383426 B383602 B383686 B383799 B384104 B384167 B384309 B383348 B383473 B383603 B383688 B383800 B384105 B384170 B384311 B383349 B383476 B383604 B383690 B383801 B384106 B384172 B384315 B383350 B383481 B383606 B383692 B383803 B384107 B384173 B384318 B383353 B383483 B383610 B383694 B383805 B384108 B384174 B384320 B383354 B383486 B383612 B383696 B383806 B384109 B384177 B384326 B383358 B383487 B383614 B383697 B383807 B384111 B384178 B384340 B383359 B383492 B383615 B383698 B383808 B384113 B384179 B384348 B383360 B383497 B383617 B383699 B383809 B384114 B384180 B384349 B383362 B383498 B383618 B383701 B383811 B384115 B384221 B384350 B383364 B383501 B383619 B383702 B383814 B384116 B384223 B384351 B383365 B383509 B383620 B383704 B383815 B384117 B384227 B384352 B383366 B383514 B383621 B383705 B383817 B384118 B384228 B384353 B383367 B383521 B383623 B383706 B383818 B384119 B384229 B384354 B383369 B383523 B383624 B383707 B383819 B384120 B384230 B384356 B383371 B383524 B383625 B383708 B383821 B384121 B384231 B384357 B383373 B383530 B383627 B383709 B383822 B384122 B384232 B384360 B383374 B383531 B383629 B383710 B383823 B384123 B384233 B384361 B383375 B383532 B383632 B383711 B383825 B384124 B384236 B384363 B383376 B383534 B383633 B383714 B383828 B384125 B384237 B384364 B383379 B383537 B383638 B383722 B383829 B384126 B384242 B384369 B383380 B383540 B383642 B383729 B383831 B384127 B384244 B384370 B383382 B383541 B383643 B383731 B383832 B384129 B384245 B384371 B383385 B383542 B383644 B383733 B383840 B384131 B384246 B384372 B383387 B383549 B383647 B383735 B383845 B384132 B384247 B384374 B383388 B383552 B383648 B383737 B383847 B384133 B384248 B384376 B383389 B383554 B383649 B383738 B383852 B384134 B384249 B384377 B383390 B383558 B383652 B383739 B383853 B384135 B384252 B384379 B383391 B383564 B383656 B383742 B383856 B384136 B384253 B384380 B383393 B383569 B383657 B383743 B383857 B384138 B384260 B384382 B383394 B383572 B383658 B383747 B383858 B384139 B384266 B384383 B383395 B383573 B383660 B383748 B383860 B384141 B384267 B384384 B383396 B383576 B383662 B383751 B383861 B384142 B384270 B384388 B383397 B383577 B383664 B383752 B383862 B384143 B384272 B384390 B383400 B383579 B383665 B383754 B383865 B384144 B384273 B384396 B383401 B383581 B383666 B383760 B383866 B384145 B384279 B384400 B383402 B383582 B383668 B383763 B383867 B384149 B384280 B384410 B384414 B384545 B384730 B384850 B385275 B385429 B385567 B385889 B384417 B384547 B384732 B384867 B385279 B385431 B385568 B385890 B384419 B384551 B384733 B384878 B385282 B385433 B385569 B385922 B384423 B384553 B384736 B384891 B385283 B385441 B385570 B385935 B384426 B384556 B384737 B384899 B385286 B385442 B385571 B385942 B384428 B384568 B384739 B384907 B385288 B385443 B385573 B386348 B384430 B384569 B384740 B384911 B385289 B385455 B385574 B386351 B384434 B384572 B384742 B384913 B385291 B385456 B385594 B386352 B384437 B384573 B384744 B384916 B385292 B385457 B385604 B386359 B384438 B384574 B384747 B384919 B385294 B385458 B385607 B386363 B384440 B384575 B384748 B384921 B385295 B385465 B385612 B386364 B384441 B384578 B384749 B384924 B385297 B385466 B385613 B386367 B384444 B384579 B384750 B384925 B385300 B385478 B385614 B386372 B384447 B384580 B384751 B384928 B385301 B385479 B385618 B386373 B384449 B384581 B384752 B384929 B385303 B385480 B385619 B386379 B384451 B384584 B384753 B384930 B385307 B385482 B385621 B386380 B384457 B384585 B384755 B384933 B385308 B385486 B385622 B386383 B384466 B384586 B384756 B384934 B385309 B385488 B385623 B386384 B384475 B384588 B384757 B384939 B385315 B385491 B385627 B386385 B384477 B384589 B384758 B384958 B385320 B385495 B385629 B386387 B384480 B384590 B384761 B384961 B385321 B385497 B385632 B386422 B384488 B384593 B384762 B384965 B385322 B385499 B385633 B386426 B384489 B384599 B384764 B384971 B385324 B385500 B385635 B386428 B384491 B384600 B384766 B384972 B385325 B385501 B385636 B386429 B384492 B384601 B384767 B384974 B385326 B385502 B385638 B386430 B384497 B384602 B384770 B384976 B385330 B385506 B385639 B386431 B384501 B384609 B384771 B384980 B385331 B385507 B385640 B386432 B384505 B384638 B384772 B384984 B385333 B385512 B385641 B386435 B384506 B384641 B384773 B384986 B385338 B385519 B385642 B386436 B384507 B384643 B384774 B384991 B385340 B385525 B385644 B386437 B384509 B384646 B384776 B385001 B385344 B385526 B385645 B386438 B384510 B384647 B384816 B385003 B385346 B385527 B385648 B386444 B384511 B384648 B384820 B385004 B385348 B385529 B385754 B386446 B384513 B384649 B384821 B385215 B385350 B385531 B385817 B386449 B384517 B384651 B384822 B385219 B385353 B385532 B385819 B386451 B384520 B384657 B384823 B385232 B385354 B385535 B385823 B386452 B384522 B384709 B384825 B385236 B385355 B385538 B385829 B386454 B384524 B384711 B384827 B385243 B385358 B385540 B385845 B386457 B384526 B384713 B384829 B385246 B385363 B385543 B385848 B386465 B384527 B384715 B384834 B385249 B385364 B385544 B385851 B386467 B384530 B384716 B384835 B385253 B385367 B385546 B385853 B386471 B384532 B384717 B384836 B385255 B385374 B385550 B385862 B386484 B384533 B384719 B384840 B385257 B385377 B385551 B385865 B386545 B384535 B384722 B384843 B385266 B385381 B385556 B385871 B386546 B384540 B384724 B384845 B385267 B385393 B385558 B385878 B386547 B384541 B384727 B384847 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  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: USA including states of: AL,AZ, CA, CO, CT, FL, GA, HI, KY, IA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV.
  • Product Description
    nanoFLEX CC4204A Intraocular Lens || Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Staar Surgical Co., 1911 Walker Ave, Monrovia CA 91016-4846
  • Manufacturer Parent Company (2017)
  • Source
    USFDA