Events

Recall of SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with -3.25 DS, || -1.25DC, 170 degree Axis. Firm on label: Manufactured by Bausch & Lomb, Waterford, Ireland.

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
    31043
  • Event Risk Class
    Class 3
  • Event Number
    Z-0544-05
  • Event Initiated Date
    2005-02-04
  • Event Date Posted
    2005-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37056
  • 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
    Lenses, Soft Contact, Daily Wear - Product Code LPL
  • Reason
    Portion of lot contains lenses with incorrect refractive power.
  • Action
    Letters issued dated February 4, 2005. The letters are flagged 'URGENT MEDICAL DEVICE RECALL'. Distributors are instructed to notify their customers to the retail (practitioner) level. All customers are instructed to return product.

Device

SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 le...
  • Model / Serial
    Carton lot W44090230; Blister Lot W44089478
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    There are 134 eye care practitioners, 191 mass retailers, 19 distributors, 14 consumers, and 3 mail order businesses.
  • Product Description
    SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with -3.25 DS, || -1.25DC, 170 degree Axis. Firm on label: Manufactured by Bausch & Lomb, Waterford, Ireland.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

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