Events

Recall of TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AMO CANADA COMPANY.

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
    98332
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Amo is initiating this action due to detection of an inspection equipment malfunction that resulted in a total of 58 distributed lenses not being fully checked prior to release. it has been identified that this malfunction may result in the release of mislabelled intraocular lenses. use of a mislabelled intraocular lens could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention. intraocular lenses with serial numbers included in the recall letter that have been implanted and resulted in an appropriate post-op refractive outcome are not affected by this action.

Device

TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: PCB00 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: AR40E (Lot serial: 2015871503); Model Catalog: ZXR00 (Lot serial: 8496921508); Model Catalog: ZCB00 (Lot serial: 5152641501); Model Catalog: ZCB00 (Lot serial: 5152541501); Model Catalog: ZCB00 (Lot serial: 5152621501); Model Catalog: ZCB00 (Lot serial: 5152481501); Model Catalog: ZCB00 (Lot serial: 5152561501); Model Catalog: ZCB00 (Lot serial: 5152601501); Model Catalog: ZCB00 (Lot serial: 5152501501); Model Catalog: ZCB00 (Lot serial: 5152461501); Model Catalog: ZCB00 (Lot serial: 5152581501); Model Catalog: ZCB00 (Lot serial: 5152661501)
  • Product Description
    TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM;SENSAR FOLDABLE IOL WITH OPTIEDGE;TECNIS SYMFONY EXTENDED RANGE OF VISION IOL;TECNIS 1-PIECE ACRYLIC ASPHERIC IOL
  • Manufacturer
    AMO CANADA COMPANY

Manufacturer

AMO CANADA COMPANY