Events

Recall of Device Recall Optima

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bausch & Lomb 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
    25105
  • Event Risk Class
    Class 3
  • Event Number
    Z-0348-03
  • Event Initiated Date
    2002-11-26
  • Event Date Posted
    2002-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25197
  • 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
    Lenses, Soft Contact, Extended Wear - Product Code LPM
  • Reason
    Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.
  • Action
    Letters dated 12/2/02 issued to distributors and practitioners requesting return of the affected lot.

Device

Device Recall Optima
  • Model / Serial
    Lot R21000211
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. || Each box contains six lenses.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

Bausch & Lomb Inc
  • Manufacturer Address
    Bausch & Lomb Inc, 1400 North Goodman St, P.O. Box 30450, Rochester NY 14609
  • Source
    USFDA