BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3955553 · Received July 24, 2014

    Report

    Report Number
    2648035-2014-00373
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION REVEALED THAT THE LENS HAS SURFACE RESIDUALS ADHERED TO BOTH SIDES OF THE OPTIC BODY COMPATIBLE WITH HANDLING THE LENS OUT OF A STERILE ENVIRONMENT. ALSO, ONE OF LENS LOOP (HAPTIC) IS DETACHED; THIS COULD BE RELATED WITH THE EXPLANT PROCESS. ADDITIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED ITEM. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED. ALL PROCESS OPERATIONS IN THE MANUFACTURING WERE IN COMPLIANCE WITH MANUFACTURING PROCEDURE SPECIFICATIONS. NO DEVIATION OR NONCONFORMANCE WAS FOUND RELATED TO THE COMPLAINT TYPE REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (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 AN ZA9003 INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE, THE IOL BECAME DISLOCATED. THIS WAS NOTED ON (B)(6) 2014 AND THE SURGEON INDICATED THAT HE WOULD NEED TO EXPLANT THE IOL. THE EXPLANT TOOK PLACE ON (B)(6) 2014. DURING THAT PROCESS, THE CAPSULE TORE AND A VITRECTOMY WAS REQUIRED. A DIFFERENT IOL WAS PLACED DURING THE SAME PROCEDURE. AN INCISION ENLARGEMENT WAS NOT REQUIRED TO REMOVE THE IOL. THE PATIENT WAS NOTED TO HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434634 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention