BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3200524 · Received July 1, 2013

    Report

    Report Number
    2648035-2013-00272
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INTRAOCULAR LENS (IOL) WAS NOT EXPLANTED IN A SECONDARY PROCEDURE; IT WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION: THE INTRAOCULAR LENS WAS NOT RETURNED TO THE MANUFACTURER. MANUFACTURING RECORDS WERE REVIEWED AND FOUND TO MEET SPECIFICATIONS. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH THE MANUFACTURING SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) WAS GENERATED DURING THE MANUFACTURE OF THE DEVICE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4) - INTRAOCULAR LENS. EXPLANT OF INTRAOCULAR LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED DURING THE SAME PROCEDURE DUE TO A POSTERIOR CAPSULE TEAR. THE DOCTOR PERFORMED A VITRECTOMY. ANOTHER POSTERIOR CHAMBER LENS WAS IMPLANTED SUCCESSFULLY AND THE PATIENT WAS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300063 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention