BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2943844 · Received February 5, 2013

    Report

    Report Number
    2648035-2013-00078
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. THE IOL WAS STUCK IN THE EMERALDC CARTRIDGE; THE RETURNED ITEM HAD THE APPEARANCE OF OPHTHALMIC VISCOELASTIC ON THE LENS. FURTHER EVALUATION WAS NOT POSSIBLE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BROKEN CAPSULE WHEN INSERTING THE INTRAOCULAR LENS. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49172 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EMERALDC CARTRIDGE