Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Prescription eyeglass safety lenses

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Prescription eyeglass safety lenses see related information
Date Initiated by Firm September 12, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on October 09, 2015
Recall Number Z-0167-2015
Recall Event ID 69345
Product Classification Lens, spectacle, non-custom (prescription) - Product Code HQG
Product Prescription eyeglass safety lenses.

Vision correction
Code Information 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
Recalling Firm/
Manufacturer		 Eyemart Express Ltd
13800 Senlac Dr Ste 200
Farmers Branch TX 75234-8823
Manufacturer Reason
for Recall		 Prescription eyeglass safety lenses did not meet specifications.
FDA Determined
Cause 2		 Employee error
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.
Quantity in Commerce 76 pairs of eyeglasses
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-