medical Class II Updated 2020-05-27

Frames Direct recalls Frames Direct Prescription Spectacle Lenses included in the

Recalled Product

Frames Direct Prescription Spectacle Lenses included in the frame brands

Hazard / Issue

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.

Issued by

FDA

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/Code Info: 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,
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