Events

Recall of Device Recall Bausch & Lomb Boston Conditioning Solution Original Formula

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
    52602
  • Event Risk Class
    Class 2
  • Event Number
    Z-1735-2009
  • Event Initiated Date
    2009-06-30
  • Event Date Posted
    2009-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83443
  • 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
    Accessories, soft lens products - Product Code LPN
  • Reason
    The product failed to meet one of the shelf life specifications at the end of the expiry period.
  • Action
    Bausch & Lomb issued an "Urgent Voluntary Medical Device Recall" notice dated June 26, 2009. All consignees were requested to review their inventory, and return any of the affected product to Stericycle Pharmaceutical Services, Indianapolis, IN. A Business Reply Card was included to be returned to Bausch & Lomb via US mail. A prepaid UPS Packing Slip was also provided to return the affected product. For further questions, contact Bausch & Lomb Customer Resource Center at 1-800-828-9030.

Device

Device Recall Bausch & Lomb Boston Conditioning Solution Original Formula
  • Model / Serial
    Lot Number: GA7060; Item Number: 7474G. Expires January 2009.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Bausch & Lomb, Boston¿ Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester, NY 14609.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

Bausch & Lomb Inc
  • Manufacturer Address
    Bausch & Lomb Inc, 1400 North Goodman Street, Rochester NY 14609-3547
  • Source
    USFDA