BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13056667 · Received December 21, 2021

    Report

    Report Number
    3012236936-2021-00333
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 21, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PT INFO: UNKNOWN/ NOT PROVIDED. CATALOG NUMBER : A COMPLETE CATALOG # IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE : UNKNOWN/NOT PROVIDED. EXPLANT DATE: UNKNOWN/NOT PROVIDED. INITIAL REPORTER: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. THE DEVICE IS NOT RETURNING FOR EVALUATION AS TO DATE IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THE SERIAL NUMBER FOR THE DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DOCTOR FELT THAT THERE WAS DIFFICULTY FOR THE LENS COMING OUT OF THE INJECTOR AND THIS ALSO LEAD TO INCORRECT PLACEMENT OF THE LENS. THERE WAS AN ADDITIONAL SURGERY DONE ON THE (B)(6) 2021 TO REPOSITION THE LENS BACK INTO THE CAPSULAR BAG AND THE SURGERY WAS A SUCCESS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950277 TECNIS IOL INTRAOCULAR LENS MJP AMO PUERTO RICO MFG. INC. ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention