BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 14952486 · Received July 7, 2022

    Report

    Report Number
    3012236936-2022-01614
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    November 22, 2021
    Report Date
    July 7, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474750562
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT ETHNICITY: UNKNOWN, INFORMATION WAS ASKED, BUT WAS NOT PROVIDED. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    RECEIVED A REPORT INDICATING THE PATIENT IS EXPERIENCING BLURRY VISION AT DISTANCE. THE HEALTH CARE PROVIDER INDICATED THE SYMPTOM IS DEBILITATING. THE IOL WAS EXPLANTED AND REPLACED WITH THE SAME MODEL BUT 15.0 DIOPTER. REPORTEDLY, THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY OR SUTURES REQUIRED. THE PATIENT IS NOT ON ANY MEDICATION OUTSIDE OF THE STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985065 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DFR00V 05050474750562

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention