FDA Medical Device Recalls (openFDA)
Enchroma Inc: 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
- Recall number
- Z-0488-2025
- Recalling firm
- Enchroma Inc
- 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
- Status
- Open, Classified
- Initiated
- 2024-09-06
- Posted
- 2024-11-19
- Terminated
- not on file
- 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.
- Root 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAI
- Firm FEI
- 3009455348
- Firm city
- Berkeley
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28