BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 15983711 · Received December 14, 2022

    Report

    Report Number
    3012236936-2022-03001
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    November 23, 2022
    Report Date
    December 21, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474709881
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT: UNKNOWN/NO INFORMATION. ETHNICITY: UNKNOWN/NO INFORMATION. RACE: UNKNOWN/NO INFORMATION. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE WAS NOT EXPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT IN SECTION "G2", THE BOX FOR "FOREIGN" SHOULD HAVE BEEN SELECTED WHICH INADVERTENTLY WAS NOT; THEREFORE, THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION G2: REPORT SOURCE ADDED: FOREIGN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED A TEAR IN THE SHAPE OF A HALF MOON WAS IDENTIFIED ON THE EDGE OF THE LENS. THE DOCTOR DECIDED TO CONTINUE WITH THE IMPLANT BECAUSE HE BELIEVED THE LENS DEFECT WOULD NOT AFFECT THE OUTCOME. REPORTEDLY, THE PATIENT¿S DAILY ACTIVITIES ARE NOT SIGNIFICANTLY AFFECTED. THE INCISION WAS NOT ENLARGED, NO SUTURE, NO VITRECTOMY AND NO MEDICATION WAS PRESCRIBED. THE POST-OPERATIVE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734297 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFR00V 05050474709881

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male