FDA-Device2020-05-27Class II
Frames Direct Prescription Spectacle Lenses included in the frame brands
Frames Direct
Hazard
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.
Sold states
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
Affected count
87 pair
Manufactured in
2801 S Interstate 35 Ste 170, N/A, Austin, TX, United States
Products
Frames Direct Prescription Spectacle Lenses included in the frame brands
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2063-2020Don't want to check this manually?
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