BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 14921092 · Received July 5, 2022

    Report

    Report Number
    3012236936-2022-01747
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 3, 2022
    Report Date
    July 5, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474620650
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER REGULATION EU (B)(4) (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. IF EXPLANTED, GIVE DATE: UNKNOWN WHETHER LENS WAS EXPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). THE INTRAOCULAR LENS (IOL) HAS 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS DEPLOYED, THERE WAS A SMALL PIECE OF PLASTIC IN THE ANTERIOR CHAMBER. IT WAS NOT CLEAR TO THE SURGEON IF IT WAS FROM THE IOL OR THE INJECTOR. IT WAS LEARNED THAT EVENTS LIKE THIS OCCURRED BEFORE AND THEY HAVE BEEN REPORTED TO US ALREADY CAPTURED IN OTHER COMPLAINT FOLDERS. IT WAS NOTED THAT ON ALL EVENTS, THE PIECES WERE REMOVED WITH SMALL FORCEPS. POSTOPERATIVELY, ALL HAD NORMAL FINDINGS. THE ORIGINAL VITAN SHOOTER WAS USED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162456 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GCB00 05050474620650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VITAN UNFOLDER