Events

Recall of AKREOS AO Micro Incision Lens

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bausch & Lomb Surgical, 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
    67283
  • Event Risk Class
    Class 2
  • Event Number
    Z-1062-2014
  • Event Initiated Date
    2013-10-16
  • Event Date Posted
    2014-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125149
  • 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
    Lens was manufactured with incorrect raw material.
  • Action
    The firm, Bausch + Lomb, telephoned and sent an "URGENT - MEDICAL DEVICE RECALL" letter dated October 17, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1) Determine the disposition of the lenses; 2) Complete and provide the enclosed acknowledgement form to the sales respresentatives collecting the lenses, and 3) Return all unused products. If you have any questions, please contact Bausch + Lomb at (800) 338-2020.

Device

AKREOS AO Micro Incision Lens
  • Model / Serial
    Model Numbers(s): AO60 and MI60L
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
  • Product Description
    Bausch & Lomb AKREOS AO Micro Incision Lens || The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
  • Manufacturer
    Bausch & Lomb Surgical, Inc.

Manufacturer

Bausch & Lomb Surgical, Inc.
  • Manufacturer Address
    Bausch & Lomb Surgical, Inc., 21 N Park Place Blvd, Clearwater FL 33759-3917
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA