BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 13007003 · Received December 14, 2021

    Report

    Report Number
    3012236936-2021-00096
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 17, 2021
    Report Date
    December 14, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474654730
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE, WEIGHT, ETHNICITY: INFORMATION UNKNOWN/ NOT PROVIDED. EXPLANT DATE: LENS REMAINS IMPLANTED, THEREFOR NOT EXPLANTED. TELEPHONE NUMBER: (B)(6). OTHER: THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS THE LENS REMAINS IMPLANTED. 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR SAW A METAL SPLINTER ON THE LENS DURING LENS IMPLANTATION. THEY WERE ABLE TO REMOVE THIS SPLINTER WHICH WAS DISCARDED AND THE LENS APPEARED TO BE UNDAMAGED. NO PATIENT INJURIES WAS REPORTED AND NO MEDICAL INTERVENTIONS WERE MENTIONED. THE PATIENT HAS FULLY RECOVERED AND THE REPORTED ISSUE DID NOT AFFECT PATIENT'S DAILY ACTIVITIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897211 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GIB00 05050474654730

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown