Events

Recall of Boston ES Rigid Gas Permeable Contact lens

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
    55538
  • Event Risk Class
    Class 2
  • Event Number
    Z-1705-2010
  • Event Initiated Date
    2010-04-20
  • Event Date Posted
    2010-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91081
  • 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
    Lens, contact (other material) - daily - Product Code HQD
  • Reason
    The amount of d&c; #6 dye added to the formulation exceeded specified amounts.
  • Action
    Bausch & Lomb issued an "Urgent Voluntary Medical Device Recall" notification dated April 20, 2010. Consignees were informed of the issue and asked to identify and return all affected product to the firm. For further information, contact Bausch & Lomb, Inc. at 1-585-338-5477.

Device

Boston ES Rigid Gas Permeable Contact lens
  • Model / Serial
    Lot Number: 156PTC05.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- TX, IN and WI.
  • Product Description
    Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Bausch & Lomb, Inc. Wilmington, MA 01887. || Indicated for daily wear for the correction of refractive ametropia in aphakic and/or not-aphakic persons with non-diseased eyes.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

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