Events

Recall of Device Recall AVAIRA Soft Contact Lenses

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
    63719
  • Event Risk Class
    Class 2
  • Event Number
    Z-0631-2013
  • Event Initiated Date
    2012-11-09
  • Event Date Posted
    2013-01-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114611
  • 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, daily wear - Product Code LPL
  • Reason
    The lenses exceeded the acceptance limit for silicone oil residual.
  • Action
    The recall was conducted to the wholesale/distributor and Eye Care Practitioner level. The company contacted the Authorized Distributors by telephone, followed by written notification dated November 9, 2012. All written notifications to first consignees, for both revenue and Fit Sets, were sent by overnight mail with signature required as proof of receipt and the envelopes were marked "Urgent". The notifications described the issue and provided recommended actions. Customers may contact 800-341-2020 if questions.

Device

Device Recall AVAIRA Soft Contact Lenses
  • Model / Serial
    10447500016006, 10519550007006, 10537500016014
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide, including Puerto Rico, and Canada.
  • Product Description
    AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
  • 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