Events

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-2274-2014
  • Event Initiated Date
    2014-05-13
  • Event Date Posted
    2014-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127705
  • 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

Device Recall TECNIS CL
  • Model / Serial
    1016841311 1036331309 1190471309 1191411309 1221461309 1016851311 1036341309 1190481309 1191421309 1221471309 1016871311 1036351309 1190491309 1191431309 1221481309 1016891311 1036371309 1190501309 1191441309 1221491309 1016911311 1036381309 1190511309 1191461309 1221501309 1016931311 1036401309 1190521309 1191471309 1221521309 1016951311 1036421309 1190531309 1191481309 1221531309 1016971311 1036431309 1190541309 1220991309 1221541309 1016991311 1036451309 1190551309 1221011309 1221551309 1017011311 1036461309 1190561309 1221021309 1221561309 1017031311 1036471309 1190571309 1221031309 1221571309 1017051311 1036491309 1190581309 1221041309 1221581309 1017071311 1036511309 1190591309 1221051309 1221591309 1017091311 1036521309 1190601309 1221061309 1221601309 1017111311 1036531309 1190611309 1221071309 1221611309 1017131311 1036541309 1190621309 1221081309 1221621309 1017151311 1036561309 1190631309 1221091309 1221631309 1017171311 1036581309 1190641309 1221111309 1221641309 1017191311 1036591309 1190661309 1221151309 1221651309 1017211311 1036601309 1190681309 1221171309 1221661309 1017231311 1036611309 1190701309 1221181309 1221671309 1020891311 1036621309 1190721309 1221191309 1221681309 1020901311 1036631309 1190751309 1221201309 1221691309 1021091311 1036641309 1190761309 1221211309 1221701309 1021201311 1036651309 1190771309 1221221309 1221721309 1021221311 1036671309 1190781309 1221231309 1221741309 1021241311 1036691309 1190791309 1221241309 1221761309 1021261311 1036751309 1190891309 1221251309 1221801309 1021281311 1036871309 1190931309 1221261309 1221821309 1021301311 1036951309 1191031309 1221271309 1221841309 1021321311 1036981309 1191061309 1221281309 1221861309 1021341311 1037001309 1191081309 1221291309 1221871309 1021361311 1037021309 1191101309 1221311309 1221881309 1021381311 1037041309 1191171309 1221331309 1221901309 1021401311 1037061309 1191181309 1221351309 1221921309 1021421311 1037071309 1191191309 1221361309 1221941309 1036181309 1037091309 1191211309 1221371309 1221951309 1036201309 1037111309 1191231309 1221381309 1221961309 1036221309 1190391309 1191271309 1221391309 1221971309 1036241309 1190411309 1191291309 1221401309 1221981309 1036271309 1190421309 1191311309 1221411309 1222001309 1036281309 1190431309 1191331309 1221421309 1222021309 1036291309 1190441309 1191351309 1221431309 1222031309 1036311309 1190451309 1191371309 1221441309 1222041309 1036321309 1190461309 1191391309 1221451309 1222061309 1222081309 1018561311 1019201311 1049981309 1108671309 1109161309 1227091309 1018571311 1019221311 1050201309 1108681309 1109201309 1227101309 1018581311 1019231311 1050221309 1108691309 1109221309 1227121309 1018591311 1019241311 1050241309 1108701309 1109241309 1227141309 1018601311 1019251311 1050261309 1108711309 1109251309 1227151309 1018611311 1019271311 1050271309 1108721309 1109271309 1227171309 1018621311 1019291311 1050281309 1108731309 1109281309 1227191309 1018641311 1019311311 1050301309 1108741309 1109291309 1227211309 1018651311 1019351311 1050321309 1108751309 1109311309 1227231309 1018661311 1019371311 1050341309 1108761309 1109331309 1227241309 1018671311 1019391311 1050361309 1108771309 1109351309 1227251309 1018691311 1019411311 1050381309 1108781309 1109371309 1227261309 1018711311 1019431311 1050401309 1108791309 1109391309 1227271309 1018731311 1019451311 1050421309 1108801309 1109411309 1227281309 1018751311 1019471311 1050491309 1108811309 1109431309 1227291309 1018771311 1019491311 1050511309 1108821309 1109451309 1227301309 1018781311 1019511311 1050531309 1108831309 1109471309 1227311309 1018791311 1019531311 1050541309 1108841309 1109481309 1227331309 1018801311 1019551311 1050561309 1108851309 1226581309 1227351309 1018811311 1019571311 1050581309 1108871309 1226601309 1227371309 1018821311 1019581311 1050601309 1108891309 1226641309 1227391309 1018831311 1019591311 1108421309 1108901309 1226661309 1227411309 1018841311 1019611311 1108431309 1108911309 1226681309 1227421309 1018851311 1019711311 1108441309 1108921309 1226701309 1227431309 1018861311 1049521309 1108451309 1108931309 1226801309 1227451309 1018871311 1049531309 1108461309 1108941309 1226821309 1227461309 1018881311 1049541309 1108471309 1108951309 1226841309 1227471309 1018891311 1049551309 1108481309 1108961309 1226861309 1227481309 1018901311 1049561309 1108491309 1108971309 1226871309 1227491309 1018911311 1049581309 1108501309 1108991309 1226881309 1227501309 1018921311 1049601309 1108511309 1109001309 1226891309 1227511309 1018931311 1049621309 1108521309 1109011309 1226901309 1227521309 1018941311 1049641309 1108531309 1109021309 1226911309 1227531309 1018961311 1049661309 1108541309 1109031309 1226921309 1227541309 1018981311 1049681309 1108551309 1109041309 1226931309 1227551309 1019001311 1049701309 1108561309 1109061309 1226941309 1227571309 1019021311 1049721309 1108571309 1109071309 1226951309 1227581309 1019041311 1049741309 1108581309 1109081309 1226961309 1227591309 1019061311 1049861309 1108601309 1109091309 1226971309 1227601309 1019081311 1049881309 1108611309 1109101309 1226981309 1227611309 1019101311 1049891309 1108621309 1109111309 1226991309 1227621309 1019121311 1049901309 1108631309 1109121309 1227041309 1227631309 1019141311 1049921309 1108641309 1109131309 1227061309 1227641309 1019161311 1049941309 1108651309 1109141309 1227071309 1227661309 1019181311 1049961309 1108661309 1109151309 1227081309 1227671309 1227681309 1227691309 1227701309 1227721309 1021011311 1021071311 1036361309 1036681309 1036701309 1036721309 1036761309 1036781309 1036801309 1036821309 1036861309 1036891309 1036901309 1036931309 1190381309 1190401309 1190811309 1191011309 1191131309 1191161309 1221321309 1221341309 1019211311 1019281311 1019691311 1049571309 1049591309 1050061309 1050081309 1050141309 1050161309 1050181309 1108591309 1109181309 1109191309 1109211309 1109301309 1109321309 1109341309 1109361309 1109381309 1109401309 1109421309 1109441309 1109461309 1227161309 1227181309 1227201309 1227441309 1227561309
  • Product Classification
    Ophthalmic Devices
  • 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: 12.0 and 12.5 || 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
    AMO Puerto Rico Manufacturing, Inc.

Manufacturer

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