Events

Recall of Prescription eyeglass safety lenses

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Eyemart Express Ltd.

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
    69345
  • Event Risk Class
    Class 2
  • Event Number
    Z-0167-2015
  • Event Initiated Date
    2014-09-12
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130267
  • 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
    Lens, spectacle, non-custom (prescription) - Product Code HQG
  • Reason
    Prescription eyeglass safety lenses did not meet specifications.
  • Action
    Eyemart Express sent an Important Recall Notice dated September 12, 2014, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Eyemart Express Customer Service at 1-888-DRBARNES to discuss their lens replacement options of if they have any questions.

Device

Prescription eyeglass safety lenses
  • Model / Serial
    No lot codes are applied. The recalled products contain the following model numbers: LC Elite 1.50 80mm HC, LC Elite 1.50 80mm Suntech GRY, LC Elite Poly 75mm Suntech GRY, LC Elite Poly 77mm HC, LC SFSV 1.67 Suntech3 GRY, LC SFSV 75mm Trivex STG, LC Short Elite Poly 77mm HC, LC Short Elite Poly Suntech GRY, Poly FT-28 with scratch coat, Poly LifeRX Photo FT 7x28 Brown, Poly LifeRx Photo FT-28 Gray, Poly SFSV LifeRx Photo Gray, Poly SFSV with scratch coat, SF SUMMIT ECP 167 TRN7 GY 70mm, SF SUMMIT ECP 167 TRN7 GY 75mm, SF SV 1.53 T7 GY 75mm, SF SV 70mm PHOENIX COT, SFSV 167 Clear, Transitions VI Gray D28
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AK, AL, AR, CA, LA, MD, MO, MS, MT, NC, ND, NM, OH, OK, TN, SC, TX, VA, WI, and WV.
  • Product Description
    Prescription eyeglass safety lenses. || Vision correction
  • Manufacturer
    Eyemart Express Ltd

Manufacturer

Eyemart Express Ltd
  • Manufacturer Address
    Eyemart Express Ltd, 13800 Senlac Dr Ste 200, Farmers Branch TX 75234-8823
  • Manufacturer Parent Company (2017)
    Eyemart Express Ltd.
  • Source
    USFDA