Medical device recalls Moderate risk

Frames Direct recalls Frames Direct Prescription Spectacle Lenses included in the frame brands

Recall date
March 18, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2063-2020
FDA classification
Class II
Brand / firm
Frames Direct
Sold / distributed
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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Frames Direct Prescription Spectacle Lenses included in the frame brands

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