Events

Recall of Device Recall HYPA C7

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by My Cosmetics 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
    25016
  • Event Risk Class
    Class 2
  • Event Number
    Z-0400-03
  • Event Initiated Date
    2002-11-13
  • Event Date Posted
    2002-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25017
  • 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
    Products are being distributed from importer directly to retail outlets labeled 'for cosmetic use only'.
  • Action
    Firm began to telephone contact recall customers on 11/20/2002. Letters will also be sent requesting return of any remaining stock.

Device

Device Recall HYPA C7
  • Model / Serial
    Lot numbers BB63 and BB73 on containers that hold lenses. Lot number 123410 is on inner box that holds 3 pairs of lenses.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. States of AL, AR, CA, DE, FL, GA, KY, LA, MD, MS, MO, NV, NY, NC, NE, OK, TN, TX, WA.
  • Product Description
    Cosmetic color soft contact lenses. Multiple colors which include Blue, Green, Aqua, Brown, Grey. || BesCon (brand)
  • Manufacturer
    My Cosmetics Inc

Manufacturer

My Cosmetics Inc
  • Manufacturer Address
    My Cosmetics Inc, 9950 Bell Ranch Dr Ste 106, Santa Fe Springs CA 906706159
  • Source
    USFDA