Class 2 Device Recall EnChroma Safety Glasses with Rx Indoor Universal Lenses

• Date Initiated by Firm: September 06, 2024
• Date Posted: November 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0488-2025
• Recall Event ID: 95461
• Product Classification: Lens, prescription, color deficiency - Product Code NAI
• 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
• Code Information: 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
• FEI Number: 3009455348
• Recalling Firm/ Manufacturer: Enchroma Inc; 2001 Addison St # 335; Berkeley CA 94704-1192
• For Additional Information Contact: 510-497-0048
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: On 9/6/24, recall notices were emailed to customers who were asked to do the following: 1) Return affected devices. 2) immediately cease use of the devices, package and return the devices to their practice. 2) Complete and return the response form via email to perceptioneyes@gmail.com The firm will provide a full refund of to the establishment upon receipt of the returned devices as well as any extended warranty that may be associated with the devices. Customers with additional questions can contact the firm at chris.dykes@enchroma.com
• Quantity in Commerce: 53
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.