BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2790234 · Received October 15, 2012

    Report

    Report Number
    2648035-2012-00308
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION - THE LENS WAS RECEIVED AND INSPECTED REVEALING ONE MISSING HAPTIC AND A TORN OPTIC WITH EVIDENCE OF VISCOELASTIC NOTED. FOLLOW-UP WITH THE CUSTOMER INDICATED THAT THERE WAS A BENT HAPTIC OBSERVED DUE TO SURGICAL TECHNICIAN ERROR. PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) SERIAL NUMBER INITIALLY REPORTED AS THE EXPLANTED LENS WAS INCORRECT. THE CORRECT SERIAL NUMBER IS (B)(4).(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LENS EXCHANGE DURING THE SAME PROCEDURE DUE TO A BENT HAPTIC. IT WAS STATED THAT IT WAS ATTRIBUTED TO SURGICAL TECHNICIAN ERROR. AN INCISION ENLARGEMENT WAS MADE. NO COMPLICATIONS WERE REPORTED. PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention