Z-2063-2020Class II

Frames Direct Prescription Spectacle Lenses included in the frame brands

Name: Z-2063-2020 Frames Direct Prescription Spectacle Lenses included in the frame brands
Creator: Frames Direct
Published: 2020-03-18
License: https://open.fda.gov/license/

Frames Direct / initiated 2020-03-18 / Terminated / root cause: manufacturing process

FDA source

Frames Direct began a recall of Frames Direct Prescription Spectacle Lenses included in the frame brands on 2020-03-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2063-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-18
Posted: 2020-05-20
Terminated: 2022-06-14
Recalling firm: Frames Direct
Product: Frames Direct Prescription Spectacle Lenses included in the frame brands
Product code: HQG Lens, Spectacle, Non-Custom (Prescription)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: 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,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2063-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2063-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-20

Product code HQG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)