BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3122829 · Received May 21, 2013

    Report

    Report Number
    2648035-2013-00231
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    February 5, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LENS WAS RETURNED TO OUR QUALITY ASSURANCE LABORATORY FOR INSPECTION. UPON VISUAL INSPECTION, THE LENS WAS FOUND CUT AND APPEARED TO HAVE EVIDENCE OF VISCOELASTIC. THE CARTRIDGE WAS NOT RETURNED. NO FURTHER INSPECTION WAS POSSIBLE DUE TO THE CONDITION OF THE RECEIVED LENS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) WAS GENERATED FOR THIS PRODUCTION ORDER. BASED ON THE MANUFACTURING RECORD REVIEW, NO DEVIATION OR ASSIGNABLE CAUSE WAS IDENTIFIED FOR THE COMPLAINT TYPE REPORTED. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS, (IOL) THAT THE OPTIC HAD A DEFECT. TO REMOVE THE LENS, AN INCISION ENLARGEMENT WAS REQUIRED. ANOTHER LENS (SAME MODEL) WAS PLACED IN THE SAME PROCEDURE AND SUTURE WAS USED TO CLOSE THE INCISION. NO PATIENT INJURY WAS REPORTED. IN FOLLOW UP THE ''DEFECT'' WAS NOTED TO BE A FOREIGN MATERIAL ON THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223801 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention