Events

Recall of Biomedics Toric

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cooper Vision Caribbean Corp..

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
    69496
  • Event Risk Class
    Class 2
  • Event Number
    Z-0529-2015
  • Event Initiated Date
    2014-10-28
  • Event Date Posted
    2014-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130762
  • 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
    Portions of the lots may contain units with an incorrect lens axis condition.
  • Action
    This recall is being initiated to the wholesale/distributor and Eye Care Practitioner level. Written communications will be forwarded to all first level consignees by overnight mailin..9. Receipt" tracking and follow up with consignees will be conducted according to the Effectiveness Check noted below. . - . The 0ff Axis condition is ~onsistent with a situation in which use of, or exposure to, the product is unlikely to cause adverse health consequences. A user may notice blurred vision due¿ to the axis being out of specification but removal of the lens effectively reduces/eliminates any impairment. There is currently no indication that use of a lens with an Off Axis condition will create an injury requiring medical intervention. No permanent impairment is anticipated with or without medical intervention. Based on the analysis " described in the attached Health Hazard Evaluation, CooperVision will initiate a Class Ill recall. As noted by regulation, this classification is consistent with a situation in which use of, or exposure to, the product is unlikely .to cause adverse health consequences. Our evaluation of the Off Axis condition indicates it is unlikely to cause an adverse health reaction. Based on a Class Ill determination, the recall shall be conducted to the Wholesale level with a planned Effectiveness Check at Level B - 50% of Consignees to be contacted. Public Warning- in light of the low risk and proposed recall classification; a public warning is not warranted at this time. Distribution includes: " North America: Canada, USA " Latin America: Argentina, Brasil, Chile, Colombia, Ecuador, Guatemala, Uruguay, Venezuela, Mexico " Europe: Belgium, Denmark, Germany, France, Netherlands, Poland, Spain, Sweden, Switzerland " Australia Returned lenses will be quarantined from distribution and destroyed as required. Actions and Dates: " Notify FDA through 806 Form on 10/23/14 " Initiate External communications starting 10/28/2014 " C

Device

Biomedics Toric
  • Model / Serial
    Lots # 8246525202 & 8255525096
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Soft Contact Lens
  • Manufacturer
    Cooper Vision Caribbean Corp.

Manufacturer

Cooper Vision Caribbean Corp.
  • Manufacturer Address
    Cooper Vision Caribbean Corp., 500 Road 584, Amuelas Industrial Park, Juana Diaz PR 00795
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA