BEUDAMED
    FDA Recall Open, Classified

    Alcon Custom Pak Surgical Procedure Pack

    Recall: Z-0354-2023 · Initiated October 31, 2022

    Recall

    Recall Number
    Z-0354-2023
    Event Number
    91105
    Firm
    Alcon Research, LLC
    FEI Number
    1000117501
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 31, 2022
    Posted
    December 1, 2022
    Address
    9965 Buffalo, Speedway Houston, TX, 77054-1309

    Description

    Alcon Custom Pak Surgical Procedure Pack

    Reason

    Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.

    Action

    On 10/31/2022, the firm sent an "URGENT: VOLUNTARY MEDICAL DEVICE FIELD CORRECTION" Letter via overnight mail informing customers about the problem, the product and the actions to be taken. Customers are instructed to: 1. See table 1 for list of affected Alcon Custom Pak lots (included in list) that were distributed to their facility. They may receive Custom Pak lots assembled prior to this Field Correction notification, and as a result, may be receiving affected inventory in future shipments. If they receive any affected lots in the future, they will be identified by a sticker. The stickers will state (in red print) "URGENT FIELD CORRECTION Discard enclosed 3M surgical drape. Replace with sterile standalone drape." 2. Review inventory of Alcon Custom Pak lots against the attached table. For affected lots of Custom Pak in their inventory, affix the provided stickers directly to the outside of the identified affected Custom Pak units in a location most easily seen for their facility. NOTE: Alcon Custom Pak units and standalone drapes are sterile and should not be opened prior to surgery. 3. For current on-hand affected inventory, upon opening of your identified Alcon Custom Pak for surgical use, remove and dispose of the enclosed 3M Steri-Drape Surgical Drape. Call Alcon Customer Service (1-800-862-5266) in obtaining replacement sterile standalone drapes. 4. For impacted Custom Pak inventory that will ship in the future, Alcon is planning to ship sterile stand-alone substitutions. 5. Keep Table 1 for their records should they receive any affected Alcon Custom Pak lots in the near future. For questions, contact Alcon Customer Service at 1-800-862-5266

    Distribution

    Worldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and O.U.S. (foreign) to countries of: Australia, Canada, France, Germany, Italy, Mexico, New Zealand, Portugal and United Kingdom.

    Quantity

    308,610 kits