BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 14283380 · Received May 4, 2022

    Report

    Report Number
    3012236936-2022-01072
    Event Type
    Injury
    Date Received
    May 4, 2022
    Report Date
    May 3, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474606364
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE EXACT DATE IS UNKNOWN, THE BEST ESTIMATE IS BETWEEN BETWEEN MAY 13, 2021 AND MAR 24, 2022. THE DEVICE HAS NOT RETURNED FOR EVALUATION. THEREFORE, A VISUAL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO GLARE AND PATIENT NOT BEING HAPPY WITH THE LENS. ACCOUNT INDICATED THAT THE CAPSULE TORE DURING THE PROCEDURE AND A VITRECTOMY WAS PERFORMED. SUTURES WERE REQUIRED TO PREVENT INJURY. INITIALLY, THE PATIENT WAS LEFT APHAKIC. EVENTUALLY, A BAUSCH & LOMB ANTERIOR CHAMBER LENS WAS PLACED AS THE REPLACEMENT IOL. THE HEALTH CARE PROVIDER REPORTED THE SYMPTOMS AS DEBILITATING TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617632 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXT300 05050474606364

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention