Recall of Device Recall TECNIS CL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AMO Puerto Rico Manufacturing, Inc..

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
    68346
  • Event Risk Class
    Class 2
  • Event Number
    Z-2271-2014
  • Event Initiated Date
    2014-05-13
  • Event Date Posted
    2014-08-26
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-05-18
  • 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
    Units may be labeled with the incorrect diopter power.
  • Action
    AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions: 1. Stop using and remove from your inventory the affected product. 2.Complete and return the included Facsimile Form as AMO. If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.

Device

  • Model / Serial
    1193901309 1193981309 1194001309 1194021309 1194041309 1194061309 1194081309 1194101309 1194121309 1194141309 1194161309 1194181309 1194191309 1194201309 1194221309 1194231309 1194251309 1194321309 1194351309 1194371309 1194411309 1194541309 1194551309 1194591309 1194611309 1194631309 1194651309 1194801309 1301391308 1301411308 1301471308 1301491308 1301511308 1301531308 1301551308 1301571308 1301591308 1301611308 1301631308 1301671308 1301751308 1301981308 1039461309 1039481309 1039521309 1039541309 1039561309 1039581309 1039601309 1039621309 1039641309 1114081309 1114411309 1114431309 1114621309 1114841309 1114861309 1114871309 1114881309 1114891309 1114921309 1297261308 1297361308 1297411308 1297491308 1297511308 1297561308 1297571308 1297581308 1297601308 1297801308 1169561309 1169601309 1169641309 1169681309 1169691309 1169721309 1169731309 1169761309 1169791309 1169801309 1169831309 1169841309 1169871309 1169891309 1169911309 1169931309 1169971309 1170011309 1170051309 1170091309 1170131309 1170171309 1170211309 1170411309 1170431309 1170451309 1170491309 1170501309 1170511309 1170551309 1170581309 1170591309 1032921309 1032941309 1033101309 1033141309 1033161309 1033181309 1033261309 1033281309 1033301309 1033341309 1033361309 1033381309 1033401309 1033441309 1033461309 1033471309 1033481309 1033491309 1033511309 1033521309 1033531309 1033541309 1033561309 1033571309 1033581309 1033591309 1033601309 1033611309 1033621309 1033631309 1033641309 1033651309 1033661309 1033671309 1033681309 1033691309 1033701309 1033721309 1033731309 1033751309 1033811309 1037161309 1037181309 1037211309 1037231309 1037251309 1037271309 1037321309 1037341309 1037351309 1037361309 1037371309 1037381309 1037391309 1037401309 1037411309 1037421309 1037431309 1037441309 1037451309 1037461309 1037471309 1037481309 1037491309 1037511309 1037531309 1037551309 1037571309 1037581309 1037591309 1037601309 1037621309 1037641309 1037651309 1037661309 1037671309 1037681309 1037691309 1037751309 1037771309 1037861309 1037871309 1037891309 1037911309 1037951309 1052281312 1052321312 1053091312 1053191312 1053211312 1029841309 1029861309 1191501309 1191521309 1191541309 1191561309 1191581309 1191601309 1191621309 1191641309 1191681309 1191691309 1191711309 1191721309 1191731309 1191761309 1191881309 1192031309 1192051309 1192151309 1192171309 1192191309 1192211309 1192251309 1192281309 1192301309 1192321309 1192501309 1192521309 1192591309 1192611309 1192631309 1227911309 1228251309 1228271309 1228291309 1228511309 1228591309 1228661309 1010401309 1010411309 1010421309 1010431309 1010441309 1010451309 1010461309 1010471309 1010481309 1010491309 1010501309 1010511309 1010521309 1010541309 1010561309 1010581309 1010601309 1010611309 1010621309 1010641309 1010651309 1010671309 1010691309 1010701309 1010711309 1010851309 1010941309 1010961309 1010981309 1173861309 1173881309 1173901309 1173921309 1173941309 1173961309 1173981309 1174081309 1174151309 1174171309 1174181309 1174191309 1174201309 1174221309 1174241309 1174261309 1174281309 1174301309 1174321309 1174341309 1174361309 1174441309 1174461309 1174481309 1174491309 1174501309 1174511309 1174531309 1174551309 1174561309 1174581309 1174601309 1174621309 1174631309 1174641309 1174651309 1174671309 1174681309 1174691309 1174701309 1174711309 1174721309 1174731309 1174801309 1174821309 1174831309 1174841309 1012311309 1012351309 1012371309 1012391309 1012411309 1012471309 1012611309 1012771309 1012791309 1012811309 1012991309 1013011309 1013031309 1013051309 1013071309 1013091309 1013111309 1013211309 1013291309 1223331310 1223351310 1223371310 1223391310 1223571310 1223591310 1223611310 1223631310 1223651310 1223671310 1223681310 1223691310 1223701310 1223711310 1223721310 1223751310 1223891310 1223911310 1223931310 1223951310 1224021310 1224031310 1224041310 1224061310 1224071310 1224081310 1224101310 1224111310 1224121310 1224141310 1224161310 1224171310 1224211310 1224221310 1224241310 1224261310 1224271310 1224281310 1224291310 1224301310 1224321310 1104141309 1104191309 1104201309 1104281309 1104301309 1104321309 1104331309 1104341309 1104351309 1104361309 1104371309 1104381309 1104391309 1104401309 1104411309 1104421309 1104431309 1104441309 1104451309 1104471309 1104491309 1104531309 1104551309 1104571309 1104581309 1104601309 1104621309 1104641309 1104661309 1104681309 1104691309 1104711309 1104771309 1104791309 1104811309 1104831309 1104891309 1104911309 1104921309 1104941309 1104961309 1105001309 1294501308 1294511308 1294521308 1294531308 1294551308 1294561308 1294571308 1294581308 1294591308 1294601308 1294611308 1294621308 1294631308 1294641308 1294651308 1294671308 1294681308 1294691308 1294701308 1294711308 1294721308 1294741308 1294751308 1294761308 1294771308 1294791308 1294811308 1294821308 1294831308 1294841308 1294851308 1294861308 1294871308 1294881308 1294891308 1294901308 1294911308 1294921308 1294931308 1294941308 1294951308 1294961308 1294971308 1294981308 1294991308 1295001308 1295021308 1295031308 1295041308 1295051308 1295061308 1295071308 1295081308 1295091308 1295101308 1295111308 1295151308 1295171308 1295181308 1295191308 1295201308 1295221308 1295231308 1295241308 1193921309 1193961309 1194171309 1194361309 1194381309 1194461309 1194621309 1194641309 1194661309 1301431308 1301941308 1114801309 1297311308 1297331308 1297391308 1298081308 1033041309 1033121309 1033171309 1033201309 1033241309 1033791309 1191511309 1228781309 1012831309 1223921310 1223941310 1224091310 1294731308 1295161308
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
  • Product Description
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 || Product Usage: || AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    AMO Puerto Rico Manufacturing, Inc., Rd # 402, Km 4.2, Anasco PR 00610
  • Source
    USFDA