Events

Recall of Device Recall Bausch & Lomb ReNu MultiPurpose Solution, Equate MultiPurpose Solution and Target Brand MultiPur

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
    37507
  • Event Risk Class
    Class 2
  • Event Number
    Z-0715-2007
  • Event Initiated Date
    2007-03-05
  • Event Date Posted
    2007-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50657
  • 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
    contact lens solution - Product Code LYL
  • Reason
    A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.
  • Action
    The firm issued a press release on 03/05/2006. Consignees were notified on 03/06/2007 via a customized Recall Notification Package via overnight courier with tracking and delivery confirmation capability. Bausch & Lomb Sales Representatives will visit the home offices of the major wholesale and distributors concurrent with the mailing of the notification packages.

Device

Device Recall Bausch & Lomb ReNu MultiPurpose Solution, Equate MultiPurpose Solution and Target ...
  • Model / Serial
    Lot numbers appearing on the bottles distributed in the U.S.: GC6030, GC6037, GC6045, GC6061, GC6063, GC6072, GC6073 and GC6085. The lots all carry the expiration date ''2008-03'' on the bottle.   Lot numbers appearing on bottles distributed only outside of the U.S.: GC6038, GC6048 and GC6052.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Argentina, Brazil, Canada, Chile, Costa Rica, Korea, Mexico, Taiwan and Venezuela.
  • Product Description
    Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu¿ Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl.oz., 12 fl. oz. and 16 fl. oz
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

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