Events

Recall of 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
    53873
  • Event Risk Class
    Class 2
  • Event Number
    Z-0553-2010
  • Event Initiated Date
    2009-10-30
  • Event Date Posted
    2009-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86782
  • 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 solution ultrasonic cleaners for lenses / products contact lens care rigid gas permeable - Product Code MRC
  • Reason
    The product failed to meet out of specification shelf life at the 9 months time point. this could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.
  • Action
    Consignees were notified by mail on/about 11/06/2009. All consignees were asked to review their inventory, and return any of the affected products to Stericycle Pharmaceutical Services. A Business Reply Card was included to be returned via US mail within 5 days. A packing slip was provided to be affixed to a pre-paid USP shipping label for return.

Device

Bausch & Lomb Boston Conditioning Solution, Original Formula
  • Model / Serial
    All lots
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide, Canada and Hong Kong
  • Product Description
    Bausch & Lomb Boston¿ Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

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