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U.S. Department of Health and Human Services

Class 2 Device Recall Frames Direct Prescription Spectacle Lenses

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 Class 2 Device Recall Frames Direct Prescription Spectacle Lensessee related information
Date Initiated by FirmMarch 18, 2020
Create DateMay 20, 2020
Recall Status1 Terminated 3 on June 14, 2022
Recall NumberZ-2063-2020
Recall Event ID 85484
Product Classification Lens, spectacle, non-custom (prescription) - Product Code HQG
ProductFrames Direct Prescription Spectacle Lenses included in the frame brands
Code Information Order numbers containing recalled spectacle lenses: 1340609, 1333848, 1336101 1336709, 1337448, 1338567, 1339053, 1339887, 1340333, 1306066, 1335064, 1336147, 1336890, 1337567, 1338633, 1339107, 1340038, 1340354, 1321063, 1335430, 1336459, 1336899, 1337701, 1338742, 1339140, 1340062, 1340380, 1323881, 1335454, 1336576, 1337053, 1337762, 1338766, 1339364, 1340160, 1340436, 1328163, 1335478, 1336597, 1337199, 1337796, 1338780, 1339530, 1340200, 1340474, 1330861, 1335614, 1336600, 1337245, 1337988, 1338876, 1339633, 1340241,1340556, 1331841, 1335664, 1336616, 1337310, 1338022, 1338889, 1339694, 1340248,1340688, 1332087, 1335916, 1336622, 1337324, 1338070, 1338900, 1339758, 1340300, 1340769, 1333701, 1335967, 1336704, 1337355, 1338080, 1339025, 1339839, 1340329, 1341058, 1341264, 1341419 1341560, 1341595, 1341670, 1342147, 
FEI Number 3010951083
Recalling Firm/
Manufacturer		 Frames Direct
2801 S Interstate 35 Ste 170
Austin TX 78741-5516
For Additional Information ContactShannon McMurrey
972-800-5206
Manufacturer Reason
for Recall		The firm has become aware through their optical laboratory supplier that prescription spectacle lenses within various frames failed to meet safety specification for shatter resistance. This could result in cracked or broken lenses.
FDA Determined
Cause 2		Process control
ActionOn 03/24/20, FramesDirect.com sent a "Urgent Medical Device recall letter via certified mail to affected consignees. The firm also emailed and phoned each affected consignee on 3/20/20. In addition to informing consignees about the recalled spectacle lenses, they asked consignees take the following action: Please discontinue use of these eyeglasses immediately and return them as soon as possible using the prepaid UPS label enclosed. The order numbers listed below have been included in this urgent medical device recall.
Quantity in Commerce87 pair
DistributionUS: Alabama,Arizona,California,Colorado,Florida,Georgia,Hawaii,Idaho,Illinois,Indiana,Kansas,Kentucky,Louisiana,Maine,Maryland,Massachusetts,Michigan,Mississippi,Missouri,Montana,Nevada,New Jersey,New Mexico,New York,North Carolina,Ohio,Oklahoma,Oregon,Pennsylvania,Puerto Rico,South Carolina,Texas,Utah,Virginia,Washington,Wisconsin OUS: Canada & Germany
Total Product Life CycleTPLC 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.
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