BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 12651143 · Received October 18, 2021

    Report

    Report Number
    2020664-2021-07757
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 9, 2021
    Report Date
    October 18, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474548671
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). THE DEVICE IS NOT RETURNING FOR EVALUATION AS IOL REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION 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 · 1

    IT WAS REPORTED THAT PATIENT HAS VISUAL DISTURBANCE FROM LAST 6 MONTHS AFTER INTRAOCULAR LENS (IOL) IMPLANTATION. HOWEVER, DUE TO COVID-19, HE DELAYED HIS VISIT TO HOSPITAL. UPON FURTHER FOLLOW-UP DURING REVIEW, SURGEON IDENTIFIED THAT IOL HAS OPACITY. PATIENT VISION IS CURRENTLY IMPAIRED AND DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. NO SURGICAL INTERVENTION PERFORMED YET. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548670 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AAB00 05050474548671

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR