EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Summary
The FDA issued a Class II for EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx by Enchroma Inc. Reason: Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, which may not provide adequate protection against impac.
Details
Source
Device Recall
External ID
Z-0488-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
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
Lot/Code Info: Order Numbers: #S166556, #S165570, #S166008, #S166145, #S166935, #S167024, #S168061, #S168409, #S168462, #S169061, #S169266, #S170297, #S170428, #S170496, #S171343, #S172249, #S172993, #S173215, #S173512, #S173548, #S173619, #S173729, #S173920, #S174701, #S174818, #S175254, #S175453, #S175681, #S175744, #S176183, #S176257, #S176715, s175356, s163884, #S163421, #s164055, s164308, s164426, s165796, s164324, s162314, s160669, s160666, s159817, s161084, #s160752, ecp11546,#ECP11807, #ECP11063, ecp11867, ecp10693, s166343, s174985
Quantity Affected: 53
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.
Distribution
Worldwide distribution: US (nationwide): IL, OH, NC, IA, AL, SC, NJ, TX, CO, PA, FL, MI, NY, DU, NM, CA, NH, MT, WV, KY, OR, MA, WI, VA, AZ and OUS (foreign): United Arab Emirates, Japan, and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-06
Company
Berkeley, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 280 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Enchroma Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Enchroma Inc have FDA actions?
This is the only FDA action we have on record for Enchroma Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0488-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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