FDA recall Z-2063-2020

Product

Frames Direct Prescription Spectacle Lenses included in the frame brands

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.

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

Key facts

Status

Terminated

Initiation date

2020-03-18

Report date

2020-05-27

Termination date

2022-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2063-2020