BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2701240 · Received August 15, 2012

    Report

    Report Number
    2648035-2012-00246
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 25, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #: ZA90030265, EXPIRATION DATE:10/31/2016, SERIAL #: (B)(4). IF IMPLANTED, GIVE DATE: (B)(6) 2012. DEVICE MANUFACTURE DATE: 10/01/2011. ADDITIONAL INFORMATION PROVIDED STATED THAT THE PATIENT HAD THE EXPLANT ON THEIR LEFT EYE WITH AN INCISION MEASURING 3.5MM. THE CUSTOMER HAD INITIALLY REPORTED THE EXPLANT HAD OCCURRED ON THE PATIENTS RIGHT EYE (OD). WE HAVE NOW LEARNED THAT THE PATIENT HAD THE LEFT EYE (OS) IOL EXPLANTED. THE EXPLANTED LENS WAS RECEIVED FOR EVALUATION AND THE LENS BELONGED TO THE MANUFACTURING PRODUCTION ORDER OF A SIZE 26.5 DIOPTER, MODEL ZA9003. THE LENS WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. THE QUALITY TECHNICIAN CONFIRMED THAT THE LENS WAS A MODEL ZA9003 BASED ON THE CHARACTERISTICS OBSERVED. THE LENS HAD SURFACE RESIDUALS ADHERED TO BOTH SIDES OF THE OPTIC BODY COMPATIBLE WITH AN EXPLANTED LENS. THE LENS WAS CLEANED TO REMOVE CONTAMINATION; THE LENS WAS VISUALLY INSPECTED WITH NO OTHER COSMETIC DEFECTS FOUND AND INSPECTED THE LENS FOR OPTICAL PROPERTIES. THE RESULTS SHOWED THAT THE LENS DIOPTER CORRESPONDED TO A SIZE 26.5 DIOPTER LENS. A REVIEW OF THE MANUFACTURING RECORD DOCUMENTATION FOUND THIS LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO IMPROPER INTRAOCULAR LENS (IOL) POWER. PATIENT WAS REPORTED TO BE OKAY DURING POST EXAMINATION.

    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 69 YR Required Intervention