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-2271-2014
  • 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=127386
  • 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
    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1308 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
    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: 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
    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