BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2252423 · Received September 17, 2011

    Report

    Report Number
    2648035-2011-00210
    Event Type
    Injury
    Date Received
    September 17, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RECEIVED AND VISUALLY INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. RESULTS SHOWED A LENS WITH A DISTORTED HAPTIC AND DRIED SOLUTION ON THE OPTIC. PRIOR TO RELEASE TO THE MARKET THE LENS MET ALL MANUFACTURING SPECIFICATIONS. THE INFORMATION RECEIVED FROM THE INITIAL REPORTER AND IN FOLLOW-UP SUGGESTS THIS EVENT WAS NOT CAUSED BY THE LENS BUT INSTEAD BY THE PATIENT'S EYE CONDITION. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT DURING ROUTINE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT THE SURGEON HIT THE VITREOUS DUE TO THE PATIENT'S HARD CATARACT. THE LENS COULD NOT BE IMPLANTED AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention