Events

Recall of Device Recall Bausch & Lomb

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bausch & Lomb Surgical, 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
    29055
  • Event Risk Class
    Class 2
  • Event Number
    Z-1093-04
  • Event Initiated Date
    2004-02-27
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33076
  • 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
    Lens may be labeled with incorrect diopter size.
  • Action
    The firm telephoned direct medical facility consginees on 2/27/2004 instructing to determine the disposition of the lenses and to return unimplanted ones. Follow-up phone calls were made in March 2004 for unresolved consignees.

Device

Device Recall Bausch & Lomb
  • Model / Serial
    8XRJ
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH.
  • Product Description
    SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
  • Manufacturer
    Bausch & Lomb Surgical, Inc.

Manufacturer

Bausch & Lomb Surgical, Inc.
  • Manufacturer Address
    Bausch & Lomb Surgical, Inc., 21 N Park Place Blvd, Clearwater FL 33759-3917
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA