BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 21389444 · Received February 14, 2025

    Report

    Report Number
    3012236936-2025-000044
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 14, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE LENS WAS IMPLANTED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE LENS WAS IMPLANTED. THEREFORE, IT WAS NOT EXPLANTED. SECTION D10, CONCOMITANT, MEDICAL PRODUCTS: EMERALDC CARTRIDGE. OPHTHALMIC VISCOSURGICAL DEVICE (OVD), BALANCED SALT SOLUTION (BSS). SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN 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. AN ATTEMPT WAS MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BACK HAPTIC ON THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS KINKED. THE IOL CONTACTED THE PATIENT¿S EYE BUT WAS NOT USED. REPORTEDLY, THE EMERALDC CARTRIDGE WAS USED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR IOL FROM JOHNSON AND JOHNSON. THERE WERE NO COMPLICATIONS SUCH AS AN INCISION ENLARGEMENT OR VITRECTOMY. ADDITIONALLY, BOTH THE OPHTHALMIC VISCOSURGICAL DEVICE (OVD) AND BALANCED SALT SOLUTION (BSS) WERE ALLOWED TO ACCLIMATIZE TO ROOM TEMPERATURE. AFTER THE INSERTER WAS PREPARED THERE WERE NO DELAYS IN THE SURGERY BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623451 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EMERALDC CARTRIDGE. OVD, BSS.