Events

Recall of Device Recall SoFlex SE Foldable Intraocular 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
    53949
  • Event Risk Class
    Class 2
  • Event Number
    Z-0591-2010
  • Event Initiated Date
    2009-11-19
  • Event Date Posted
    2010-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86910
  • 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
    Intraocular Lens - Product Code HQL
  • Reason
    Bausch & lomb incorporated, rochester, ny is recalling their silicone l161se intraocular lens lot 4916928 (23.5d) after receiving three customer complaints for what appears to be opacification of the intraocular lens. the opacification occurred within one week of implantation. in each reported case the surgeon explanted the lens.
  • Action
    Bausch & Lomb, Inc. notified consignees via phone beginning November 19, 2009 and by follow-up letter dated November 23, 2009. Titled "Urgent - Medical Device Recall", the letter instructed users to discontinue implantation of the affected product and return any unused lenses along with the enclosed acknowledgement form to the firm. For further information, contact Bausch & Lomb at 1-585-338-6612.

Device

Device Recall SoFlex SE Foldable Intraocular Lens
  • Model / Serial
    Model Number: LI61SE, Lot Number: 4916928.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Lenses were distributed to one distributor and 35 retailers. Worldwide Distribution -- Distributed to Canada, Taiwan and throughout the United States.
  • Product Description
    Bausch & Lomb SoFlex SE Foldable Intraocular Lens. || UPC 4001404, Rx Only, STERILE. || Manufactured by: || Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. || Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

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