Events

Recall of Device Recall Equate MutiPurpose Solution, For Soft Contact Lenses, Sterile

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
    59525
  • Event Risk Class
    Class 3
  • Event Number
    Z-3042-2011
  • Event Initiated Date
    2011-06-30
  • Event Date Posted
    2011-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103016
  • 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 - Product Code LYL
  • Reason
    Muti-purpose solution bottles, lot gc1107 were packaged in a carton that was marked with an incorrect lot code and expiration date.
  • Action
    Bausch & Lomb Inc. notified the affected customer via teleconference and e-mail on June 30, 2011. The e-mail describes the product, problem, and actions to be taken by the customer. The customer was instructed to hold and stop shipments of any inventory of the affected product. An official recall was initiated with the customer on July 8, 2011 via e-mail and teleconference. Customer was asked to review their inventory and store returns, and send any of the affected product to Bausch & Lomb Returns Dept., 130 Commerce Drive, Greenville, SC 29615.

Device

Device Recall Equate MutiPurpose Solution, For Soft Contact Lenses, Sterile
  • Model / Serial
    Lot number: GC1107
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution-in the state of AK only
  • Product Description
    Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716 || Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

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