BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3803289 · Received May 9, 2014

    Report

    Report Number
    2648035-2014-00220
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    February 27, 2014
    Report Date
    April 16, 2014
    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

    THE EXPLANTED INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED SAMPLE WAS PERFORMED AT 10X MICROSCOPE MAGNIFICATION. THE VISUAL INSPECTION REVEALED THAT THE LENS WAS RECEIVED WITH THE OPTIC EDGE TORN AND ONE (1) OF LOOPS (HAPTICS) WAS DETACHED. THE LENS FINDINGS OBSERVED COULD BE ASSOCIATED WITH THE HANDLING OF THE LENS DURING THE EXPLANT PROCESS AND HAS BEEN INDICATED AS OPERATIONAL IN THE RESULTS CODE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO QUANTITY DISCREPANCY WAS FOUND. NO DEVIATION OR NON-CONFORMANCE (NCR) WAS GENERATED DURING MANUFACTURING OF THIS PRODUCTION ORDER. THE INSPECTION DATA FOR DIOPTER POWER WAS REVIEWED AND WAS FOUND WITHIN SPECIFICATION. NO ISSUES WERE REPORTED DURING THE MANUFACTURING OF THE LENS, THE LENS MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REQUIRED TO BE EXPLANTED FROM THE LEFT EYE OF A PATIENT IN A SECONDARY PROCEDURE OWING TO DYSPHOTOPSIA. A NEW LENS WAS IMPLANTED IN THE EYE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280952 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention