BEUDAMED
    FDA Enforcement Class II Ongoing

    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

    Recall: Z-0709-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0709-2022
    Event ID
    89463
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Lacrimedics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2022
    Initiation Date
    January 17, 2022
    Classification Date
    March 1, 2022
    Address
    2620 Williamson Pl Ste 113, Dupont, WA, 98327-9518, United States

    Description

    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

    Reason

    The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

    Code Info

    CP3 010421-3358 CP3 031419-3125 CP3 032921-3429 CP3 042020-3284 CP3 052219-3149 CP3 061521-3482 CP3 071720-3322 CP3 080218-3045 CP3 091218-3057 CP3 122118-3093 CP4 010621-3377 CP4 022619-3094 CP4 041620-3285 CP4 041719-3126 CP4 072020-3323 CP4 092518-3058 CP5 011221-3359 CP5 033121-3430 CP5 042219-3127 CP5 042220-3286 CP5 072320-3324 CP5 082318-3010 CP5 111418-3059 HP7 103018-3062

    Distribution

    Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN, IL, MY, MX, NZ, PE, RO, SG, SA, TR, TW, TZ, UK

    Quantity

    4780 units