BEUDAMED
    FDA Recall Terminated

    Alcon Custom Ophthalmic Surgical Procedure Packs

    Recall: Z-1328-2021 · Initiated February 2, 2021

    Recall

    Recall Number
    Z-1328-2021
    Event Number
    87307
    Firm
    Alcon Research, LLC
    FEI Number
    1000117501
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 2, 2021
    Posted
    April 1, 2021
    Terminated
    June 30, 2023
    Address
    9965 Buffalo, Speedway Houston, TX, 77054-1309

    Description

    Alcon Custom Ophthalmic Surgical Procedure Packs

    Reason

    Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.

    Action

    On February 2, 2021 Alcon issued an :Urgent: Voluntary Medical Device Removal letter via FedEx mail to all affected consignees. On February 12, 2021 and April 9, 2021, Alcon expanded their recall to additional lots and consignees. On June 14, 2021, Alcon expanded their recall and issued an URGENT: VOLUNTARY MEDICAL DEVICE FIELD CORRECTION (FIELD ACTION EXPANSION) letter to affected consignee via FedEx. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Forward this notification to all departments or organizations using your Custom Pak. 2. See list (Table 1) of affected Alcon Custom Pak lots that were or will be distributed to your facility. You may receive Custom Pak lots assembled prior to this Field Correction notification, and as a result, you may be receiving affected inventory in future shipments. If you receive any affected Alcon Custom Pak lots in the future, they will be identified with the one of the following stickers: A. "ATTENTION DISCARD ENCLOSED GOWNS REPLACE WITH INDIVIDUALLY WRAPPED STERILE GOWSNS" or B. "URGENT FIELD CORRECTION Discard Enclosed Gowns Replace with individually wrapped sterile gowns" 3. Review your inventory of Alcon Custom Pak lots against the attached table. For Custom Pak in your inventory, affix the provided stickers directly to the outside of your identified affected Custom Pak units in a location most easily seen for your facility. NOTE: Alcon Custom Pak units and standalone gowns are sterile and should not be opened prior to surgery. 4. Upon opening of your identified Alcon Custom Pak for surgical use, remove and dispose of the enclosed surgical gowns. 5. Use separate sterile standalone surgical gowns, either your own inventory or those supplied by Alcon. 6. Please complete the attached Response Form indicating your understanding of the included instructions. 7. Return the attached Response Form via fax or email to Alcon. 8. Keep Table 1 for your rec

    Distribution

    Distribution US nationwide, including Puerto Rico; Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand

    Quantity

    249,853 Custom Packs