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-2273-2014
  • 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=127704
  • 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
    1177211309 1228981309 1177341309 1229001309 1177361309 1229021309 1177381309 1229041309 1177391309 1229061309 1177401309 1229111309 1177411309 1229191309 1177421309 1229211309 1177431309 1229221309 1177451309 1229241309 1177601309 1229261309 1177621309 1229271309 1177681309 1229281309 1177751309 1229291309 1177771309 1229301309 1177791309 1229311309 1177811309 1229321309 1177821309 1229331309 1177831309 1229341309 1177841309 1229351309 1177861309 1229381309 1177881309 1229401309 1177901309 1229501309 1177921309 1229521309 1178041309 1229541309 1178061309 1229551309 1178081309 1229561309 1178101309 1229571309 1178121309 1229581309 1178141309 1229591309 1178151309 1229601309 1178161309 1229611309 1178181309 1229621309 1178201309 1229631309 1178211309 1229651309 1178221309 1229671309 1228801309 1229681309 1228821309 1229691309 1228851309 1229701309 1228861309 1229721309 1228881309 1229741309 1228901309 1229761309 1228921309 1229771309 1228941309 1229781309 1228961309 1229811309 1229831309 1229841309 1229871309 1229881309 1177291309 1228871309 1228891309 1228911309 1229451309 1229511309 1107621309 1107721309 1107741309 1107801309 1108041309 1215161310 1224661309 1225081309 1293581308 1293621308 1294031308 1294091308 1294111308 1294251308 1107431309 1108051309 1215071310 1224861309 1293691308 1107441309 1108061309 1215091310 1224871309 1293751308 1107451309 1108071309 1215111310 1224881309 1293761308 1107471309 1108081309 1215131310 1224891309 1293771308 1107481309 1108091309 1215151310 1224911309 1293781308 1107491309 1108101309 1215171310 1224921309 1293791308 1107511309 1108111309 1215191310 1224931309 1293801308 1107521309 1108131309 1215211310 1224941309 1293811308 1107531309 1108151309 1215221310 1224951309 1293821308 1107551309 1108161309 1215241310 1224961309 1293831308 1107561309 1108171309 1215251310 1224971309 1293841308 1107571309 1108181309 1215261310 1224981309 1293851308 1107591309 1108201309 1215271310 1225001309 1293871308 1107601309 1108211309 1215281310 1225021309 1293891308 1107611309 1108221309 1215291310 1225041309 1293901308 1107631309 1108241309 1215301310 1225071309 1293911308 1107641309 1108261309 1215311310 1225091309 1293921308 1107651309 1108281309 1215331310 1225111309 1293931308 1107661309 1108301309 1215351310 1225121309 1293951308 1107671309 1108311309 1215551310 1225131309 1293971308 1107681309 1108321309 1215581310 1225141309 1293991308 1107691309 1108341309 1215601310 1225151309 1294011308 1107701309 1108361309 1215621310 1225161309 1294051308 1107711309 1108381309 1215631310 1225171309 1294071308 1107731309 1108391309 1215641310 1225191309 1294151308 1107751309 1108401309 1215651310 1225211309 1294171308 1107761309 1214701310 1215681310 1225231309 1294191308 1107771309 1214721310 1215691310 1225251309 1294211308 1107781309 1214741310 1215711310 1225271309 1294231308 1107791309 1214801310 1215731310 1225291309 1294291308 1107811309 1214821310 1224381309 1225311309 1294311308 1107821309 1214841310 1224401309 1225331309 1294331308 1107841309 1214861310 1224611309 1225351309 1294341308 1107861309 1214881310 1224631309 1225371309 1294351308 1107901309 1214901310 1224651309 1225391309 1294361308 1107911309 1214921310 1224671309 1225411309 1294371308 1107921309 1214931310 1224691309 1225431309 1294381308 1107941309 1214941310 1224711309 1293501308 1294391308 1107971309 1214951310 1224731309 1293511308 1294401308 1107981309 1214961310 1224751309 1293521308 1294411308 1107991309 1214971310 1224771309 1293531308 1294421308 1108001309 1214991310 1224791309 1293541308 1294431308 1108011309 1215011310 1224811309 1293551308 1294441308 1108021309 1215031310 1224831309 1293571308 1294451308 1108031309 1215051310 1224851309 1293671308 1294461308 1294471308 1294481308 1294491308
  • 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: 11.0 and 11.5 || 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