Recall Z-0488-2025— Enchroma Inc
Class II · Ongoing
Class II FDA medical device recall by Enchroma Inc, initiated 2024-09-06. FDA's recall record names no specific 510(k) clearance for this event. Product: EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx. Reason: Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, which may not provide adequate protection against impact, posing a risk of eye injury..
- Recalling firm
- Enchroma Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-06
- Firm location
- Berkeley, CA, United States
Product description
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx
Reason for recall
Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, which may not provide adequate protection against impact, posing a risk of eye injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.