Frames Direct Prescription Spectacle Lenses included in the frame… — Class II medical device recall Z-2063-2020
Terminated recall by Frames Direct, reported 2020-05-27, distributed in AL, AZ, CA, CO, FL, GA, HI, ID…. The firm has become aware through their optical laboratory supplier that prescription spectacle lenses within
| Recall number | Z-2063-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Frames Direct, Austin, TX, United States |
| Recall initiated | 2020-03-18 |
| Classified | 2020-05-20 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2022-06-14 |
| Distributed | AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA, WI |
| Countries outside the US | CA, DE, MX |
| Quantity | 87 pair |
| Reason classes | packaging |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2063-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.