Recall Z-2063-2020— Frames Direct
Class II · Terminated
Class II FDA medical device recall by Frames Direct, initiated 2020-03-18, terminated 2022-06-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Frames Direct Prescription Spectacle Lenses included in the frame brands. Reason: 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..
- Recalling firm
- Frames Direct
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-18
- Terminated
- 2022-06-14
- Firm location
- Austin, TX, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.