BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3202781 · Received July 2, 2013

    Report

    Report Number
    2648035-2013-00277
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER EXPLANATION: THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER UNDER A RETURNED GOODS AUTHORIZATION NUMBER THAT DID NOT INDICATE THERE HAD BEEN AN EXPLANT OR COMPLAINT. BECAUSE THE DEVICE WAS RECEIVED AS A NON-COMPLAINT, THE LENS WAS DISPOSED AND NOT EVALUATED. MANUFACTURING RECORD REVIEW: 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 LENS DIOPTER RESULT SHOWS THAT LENS CORRESPONDED TO A 8.0 DIOPTER, WHICH WAS WITHIN SPECIFICATION. NO DEVIATION WAS REPORTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT CONCERNING A PATIENT WHO HAD PREVIOUS VISION CORRECTION SURGERY (LASIK) AND SUBSEQUENTLY AN INTRAOCULAR LENS (IOL) IMPLANT. POST-IMPLANT, THE PATIENT EXPERIENCED UNEXPECTED POST-OPERATIVE REFRACTION. THE DOCTOR PERFORMED A LENS EXPLANT AND REPLACED THE IOL WITH A DIFFERENT DIOPTER LENS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301895 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention