BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 15214724 · Received August 11, 2022

    Report

    Report Number
    3012236936-2022-02141
    Event Type
    Injury
    Date Received
    August 11, 2022
    Report Date
    August 11, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN/ NOT PROVIDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY DATE OF EVENT: UNKNOWN/NOT PROVIDED, AS INFORMATION WAS ASKED AND ACCOUNT INDICATED THAT IT IS UNKNOWN. MODEL NUMBER: PARTIAL MODEL NUMBER INDICATED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: PARTIAL CATALOG NUMBER INDICATED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN/NOT PROVIDED, AS INFORMATION WAS ASKED BUT IT WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION PROVIDED AS FEB-MARCH 2022 EXPLANT DATE: UNKNOWN/NOT PROVIDED, AS INFORMATION WAS ASKED BUT IT WAS NOT PROVIDED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION; 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. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DOCTOR HAD TO EXPLANT A SYNERGY TORIC (ZFW) LENS 3-4MONTHS AFTER IMPLANT DUE TO PATIENT DISSATISFACTION. IMPLANTATION DATE: FEB-MARCH 2022. PATIENT VISION PROVIDED AS: PRE-OPERATIVE 6/7.5 FOR DISTANCE AND POST-OPERATIVE (WITH TORIC LENS IN PLACE) +0.1 S.E/ LESS THAN 0.5 CYL. PATIENT COMPLAINED OF NOT BEING ABLE TO SEE ROAD SIGNS OR PEOPLE¿S FACES UNTIL UP CLOSE DESPITE DISTANCE OF 6/7.5; PATIENT INDICATED THAT THEIR DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. DOCTOR EXPLANTED THE SYNERGY TORIC IOL FOR CLARION IN ONE EYE AND AWAITING PATIENT OUTCOMES TO SEE IF OTHER EYE NEEDS AN EXPLANT AS WELL. THE IOL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988495 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZFW

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention