Events

Recall of Device Recall AcrySof ReSTOR Intraocular Lens

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Laboratories, 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
    37009
  • Event Risk Class
    Class 2
  • Event Number
    Z-0430-2007
  • Event Initiated Date
    2006-12-14
  • Event Date Posted
    2007-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50118
  • 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 MFK
  • Reason
    Intraocular lenses exposed to extreme temperatures while in storage.
  • Action
    The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006.

Device

Device Recall AcrySof ReSTOR Intraocular Lens
  • Model / Serial
    Model MN60D3, Serial numbers: 940376.028; 945173.084; 945533.043; 945174.053; 944089.027; 942202.069; 940407.058; 940407.059; 942210.016; and 945537.073
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    AcrySof¿ ReSTOR¿ Intraocular Lens
  • Manufacturer
    Alcon Laboratories, Inc

Manufacturer

Alcon Laboratories, Inc
  • Manufacturer Address
    Alcon Laboratories, Inc, 6201 South Fwy, Fort Worth TX 76134-2001
  • Source
    USFDA