BEUDAMED
    FDA Recall Open, Classified

    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: Z-0488-2025 · Initiated September 6, 2024

    Recall

    Recall Number
    Z-0488-2025
    Event Number
    95461
    Firm
    Enchroma Inc
    FEI Number
    3009455348
    Product Code
    NAI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 6, 2024
    Posted
    November 19, 2024
    Address
    2001 Addison St, # 335, Berkeley, CA, 94704-1192

    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

    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.

    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 [email protected] 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 [email protected]

    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.

    Quantity

    53