FDA Medical Device Recalls (openFDA)
Frames Direct: Frames Direct Prescription Spectacle Lenses included in the frame brands
- Recall number
- Z-2063-2020
- Recalling firm
- Frames Direct
- Product
- Frames Direct Prescription Spectacle Lenses included in the frame brands
- Status
- Terminated
- Initiated
- 2020-03-18
- Posted
- not on file
- Terminated
- 2022-06-14
- Reason
- 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.
- Root cause
- Process control
- Action
- On 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
- 87 pair
- Distribution
- US: 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
- Lot, serial or model codes
- 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,
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HQG
- Firm FEI
- 3010951083
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28