Events

Safety Alert for TECNIS 1-Piece Intraocular Lenses

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Abbott Medical Optics.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-09-02
  • Event Date Posted
    2016-09-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160902b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: abbott medical optics tecnis 1-piece intraocular lenses medical device manufacturer, abbott medical optics, has issued a medical device safety alert concerning its tecnis 1-piece intraocular lenses (iols). [model: zcb00; diopter 24.5; serial number: 4651021512]. the manufacturer has become aware of a small number of tecnis iols that may have been mislabeled during the manufacturing process. the manufacturer is initiating this action due to detection of an inspection equipment malfunction that resulted in lenses not being fully checked prior to release. it has been identified that this malfunction may result in the release of mislabeled iols. according to the manufacturer, use of a mislabeled iol could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention. the likelihood of any impact to the patients is very low. product recall is on-going. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 september 2016.

Device

TECNIS 1-Piece Intraocular Lenses
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Medical Optics TECNIS 1-Piece Intraocular Lenses
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics