BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALENS

    MDR report key: 5632702 · Received May 4, 2016

    Report

    Report Number
    2648035-2016-00697
    Event Type
    Injury
    Date Received
    May 4, 2016
    Date of Event
    April 8, 2016
    Report Date
    September 7, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PMA#: P820049. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CUSTOMER DISPOSED OF THE LENS, THEREFORE VISUAL INSPECTION WAS NOT PERFORMED. MANUFACTURING RECORD REVIEW: A MANUFACTURING PROCESS RECORD EVALUATION COULD NOT BE PERFORMED SINCE SERIAL NUMBER OF THE DEVICE IS UNKNOWN/NOT PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED AND ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS, MODEL DURALENS PS65ATB, WAS EXPLANTED FROM AN EYE OF A FEMALE PATIENT BECAUSE THE LENS DISLOCATED (LENS SINKING TOWARDS THE INFERIOR THROUGH ZONULOLYSIS) WHICH CAUSED DETERIORATION OF HER EYESIGHT. A VITRECTOMY AND AN INCISION ENLARGEMENT (5.5MM CORNEO-SCLERAL ACCESS) WERE PERFORMED AND SUTURES WERE USED. THE SURGEON ALSO REPORTED THE VISUAL ACUITY PRE AND POST-OP. VISUAL ACUITY PRE-OPERATIVE: FZ (MIT +18DPT SPH). VISUAL ACUITY POST-OPERATIVE: 1/35 MV (SC) 2. POSTOPERATIVE DAY. THE PATIENT WAS SATISFIED WITH HER OUTCOME. THE LENS WAS DISPOSED AND WILL NOT BE SENT BACK TO THE MANUFACTURER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285722 DURALENS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PS65ATB

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention