BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2818043 · Received November 2, 2012

    Report

    Report Number
    2648035-2012-00343
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS INSPECTED WITH A MICROSCOPE AT 10X MAGNIFICATION. VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBERS, PARTICLES AND STAINS) ON THE LENS SURFACE. SURFACE RESIDUALS WERE COMPATIBLE WITH HANDLING THE LENS OUT OF STERILE ENVIRONMENT. NO OTHER UNACCEPTABLE COSMETIC DEFECT COULD BE IDENTIFIED IN THE LENS RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR TRIED TO INSERT THE LENS BUT NOTICED THE CAPSULAR BAG WAS UNSTABLE DUE TO WEAK ZONULES OF THE PATIENT ANATOMY. THE DOCTOR REMOVED THE LENS FROM INTERFACING OF THE PATIENT AND THE LENS WAS NEVER FULLY INSERTED. THE INCISION DID NOT HAVE TO BE ENLARGED BUT THE DOCTOR DID PERFORM A LIMITED VITRECTOMY AS A PRECAUTIONARY MEASURE. THE REPORTER INDICATED THIS SECONDARY PROCEDURE WAS NOT REALLY NECESSARY AS NO VITREOUS WAS LEAKING. THERE WAS NO ACTUAL COMPLAINT ON THIS LENS, THE DOCTOR WAS ABLE TO SUCCESSFULLY IMPLANT AN ANTERIOR CHAMBER LENS WITHOUT ANY FURTHER COMPLICATIONS AND THE PATIENT IS CURRENTLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE UNFOLDER PLANTINUM ONE ((B)(4))