Devices

Device Recall CUSTOMPAK

  • Model / Serial
    Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04 bearing Lot numbers 1584114H, 1577346H, 1595079H, 1589608H, 1595079H, 1585992H, 1580988H, 1585992H, and 1580492H.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including North Carolina and Maine
  • Product Description
    Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. || The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
  • Manufacturer
    Alcon Research, Ltd.
  • 1 Event

Manufacturer

Alcon Research, Ltd.
  • Manufacturer Address
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

Device Recall CustomPak Surgical Packs
  • Model / Serial
    Lot #649244H.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
  • Product Description
    Alcon Custom-Pak¿, part #10975-02, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
  • Manufacturer
    Alcon Laboratories, Inc
Device Recall CustomPak Surgical Packs
  • Model / Serial
    Lot #627618H and 636380H.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
  • Product Description
    Alcon Custom-Pak¿, part #2638-17, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
  • Manufacturer
    Alcon Laboratories, Inc
Device Recall CustomPak Surgical Packs
  • Model / Serial
    Lot #629460H, 631237H, 632356H and 642330H.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
  • Product Description
    Alcon Custom-Pak¿, part #4917-54, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
  • Manufacturer
    Alcon Laboratories, Inc
Device Recall CustomPak Surgical Packs
  • Model / Serial
    Lot #633317H, 645074H, and 629784H.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
  • Product Description
    Alcon Custom-Pak¿, part #6515-51, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
  • Manufacturer
    Alcon Laboratories, Inc
Device Recall CustomPak Surgical Packs
  • Model / Serial
    Lot #632178H, 634400H and 642229H.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
  • Product Description
    Alcon Custom-Pak¿, part #11148-02, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
  • Manufacturer
    Alcon Laboratories, Inc