BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 14866604 · Received June 30, 2022

    Report

    Report Number
    3012236936-2022-01573
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    January 7, 2022
    Report Date
    June 29, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474750708
    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 WEIGHT: THE EXACT WEIGHT IS UNKNOWN, THE BEST ESTIMATE IS APPROXIMATLY 160 TO 180 LBS. ETHNICITY: UNKNOWN/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

    A HEALTH CARE PROVIDER REPORTED THAT THEY EXPLANTED AN INTRAOCULAR LENS (IOL) FROM A PATIENT'S RIGHT EYE DUE TO THE PATIENT¿S HYPEROPIC OUTCOME RESULTING IN THEIR DISTANCE VISION BEING BLURRY. THE SYMPTOMS WERE DEBILITATING. THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY, SUTURES OR MEDICATION OUTSIDE OF THE STANDARD OF CARE. THE REPLACEMENT LENS WAS THE SAME MODEL DFR00V, BUT A DIFFERENT DIOPTER 22.0. REPORTEDLY, THE EXPLANTED IOL WILL NOT BE RETURNED DUE TO THE CUSTOMER'S PROCEDURES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874908 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DFR00V 05050474750708

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention