BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 14018366 · Received April 5, 2022

    Report

    Report Number
    3012236936-2022-00880
    Event Type
    Injury
    Date Received
    April 5, 2022
    Report Date
    April 5, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MJP
    UDI-DI
    05050474588288
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE, WEIGHT, ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: EXACT DATE UNKNOWN/NOT PROVIDED. BEST ESTIMATE DATE IS BETWEEN 92/2021- 3/10/2022. TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR ANALYSIS, 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 MISSING INFORMATION; HOWEVER, NO DEFINITIVE 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 A PATIENT HAD BILATERAL INTRAOCULAR LENSES (IOL) EXPLANTED FROM BOTH EYES AS THE PATIENT WAS NOT HAPPY WITH THEIR VISION. DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. A VITRECTOMY AND SUTURES WERE REQUIRED; HOWEVER, THE INCISION WAS NOT ENLARGED. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE PATIENT'S FIRST EYE. SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT' SECOND EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581215 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO MANUFACTURING NETHERLANDS ZCT375 05050474588288

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention