Frames Direct: Medical Device Recall in 2020 - (Recall #: Z-2063-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Frames Direct Prescription Spectacle Lenses included in the frame brands

Product Classification:

Class II

Date Initiated: March 18, 2020

Date Posted: May 27, 2020

Recall Number: Z-2063-2020

Event ID: 85484

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.

Status: Terminated

Product Quantity: 87 pair

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,

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated