Events

Recall of Biofinity XR Toric

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CooperVision 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
    79073
  • Event Risk Class
    Class 3
  • Event Number
    Z-0691-2018
  • Event Initiated Date
    2017-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161281
  • 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, extended wear - Product Code LPM
  • Reason
    The firm identified a labeling error affecting made-to-order (mto) biofinity xr toric blister labels. the primary blister reads biofinity multifocal toric in error, and should read biofinity xr toric. the outer carton correctly reads biofinity xr toric.
  • Action
    Notifications were sent with instructions to examine inventory, discard any affected inventory, and contact the firm for credit or replacement. For further questions, please call (585) 756-9273.

Device

Biofinity XR Toric
  • Model / Serial
    Exp. date 2017-07-11; Lots: R12497769, R12519016, R12508969, R12496191, R12514162, R12518889, R12483347, R12518980, R12496182, R12496192, R12498168, R12502974, R12496166, R12496196, R12501147, R12508370, R12518890, R12518978.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    USA Distribution
  • Product Description
    Biofinity XR Toric contact lenses 8.7/14.5 - 6PK || Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.
  • Manufacturer
    CooperVision Inc.

Manufacturer

CooperVision Inc.
  • Manufacturer Address
    CooperVision Inc., 180 Thruway Park Dr, W Henrietta NY 14586-9798
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA