# FDA recall Z-2063-2020

> **Frames Direct** · Class II · device recall initiated 2020-03-18.

## 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

- **Recall number:** Z-2063-2020
- **Recalling firm:** Frames Direct
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2063-2020. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-2063-2020. Source: US FDA. Licensed CC0.

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