Events

Recall of ReNu with MoistureLoc, Bausch & Lomb

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bausch & Lomb.

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
    35176
  • Event Risk Class
    Class 1
  • Event Number
    Z-1201-06
  • Event Initiated Date
    2006-04-13
  • Event Date Posted
    2006-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45456
  • 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 LPN
  • Reason
    Reports of fusarium infections among contact lens wearers.
  • Action
    Press release was issued 4/13/2006. Letters were sent via blast email to retailers, Pharmacists and Eye Care Practitioners on 04/14/2006.

Device

ReNu with MoistureLoc, Bausch & Lomb
  • Model / Serial
    All lots, all sizes
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Latin America, and Asia
  • Product Description
    Bausch & Lomb * ReNu¿ with MoistureLoc¿, Multi-purpose soft contact lens solution * Sterile * Manufactured by: Bausch & Lomb, Rochester, NY 14609.
  • Manufacturer
    Bausch & Lomb

Manufacturer

Bausch & Lomb
  • Manufacturer Address
    Bausch & Lomb, 350 Market Street, Rochester NY 14692
  • Source
    USFDA