BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL

    MDR report key: 3930252 · Received July 11, 2014

    Report

    Report Number
    2648035-2014-00338
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Removal / Correction Number
    Z-1123-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: (B)(6) 2014. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    EXPLANT DATE: LENS REMAINS IMPLANTED AT THIS TIME. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. .PLACEHOLDER

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS: REVIEW OF THE DOCUMENTATION AND TESTING PRESENTED IN THE MANUFACTURING RECORD WERE FOUND WITHIN PRODUCT SPECIFICATIONS. NO DISCREPANCY RELATED TO QUANTITY WAS FOUND. NO DEVIATION OR NON-CONFORMANCE (NCR) WAS GENERATED DURING MANUFACTURING OF THIS PRODUCTION ORDER. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED THE LENS WAS CUT IN HALF. THE HALF LENS HAD A HAPTIC AND A LOOSE HAPTIC WAS ALSO RETURNED. THE LENS WAS INSPECTED AT (B)(4) MICROSCOPE MAGNIFICATION REVEALED SURFACE SCRATCHES, AND SURFACE RESIDUALS (FIBER/PARTICLES) ON THE LENS COMPATIBLE WITH HANDLING THE LENS IN A NON-PARTICLE CONTROLLED ENVIRONMENT. DIOPTER MEASUREMENT COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP IT WAS CONFIRMED THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE ON (B)(6) 2014. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AFTER IMPLANTATION OF A Z9002 INTRAOCULAR LENS, THE PATIENT EXPERIENCED UNEXPECTED POST-OPERATIVE REFRACTION. THE SURGEON INDICATED HE WAS PLANNING ON A OUTCOME OF -0.50 AND THE RESULT WAS ABOUT -2.50. AT THIS TIME THE LENS REMAINS IMPLANTED BUT AN EXCHANGE IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405938 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R