BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 17191674 · Received June 23, 2023

    Report

    Report Number
    3012236936-2023-01577
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    May 30, 2023
    Report Date
    June 23, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474501836
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, PATIENT INFORMATION: A5: INFORMATION UNKNOWN/ASKU. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE. THERE'S NO INDICATION THE LENS WAS IMPLANTED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE. THERE'S NO INDICATION THE LENS WAS IMPLANTED. HENCE, NOT EXPLANTED. SECTION D10, CONCOMITANT MEDICAL PRODUCT: EMERALD CARTRIDGE, LOT CK20464. HEALONPRO AND ENDOCOAT. HANDPIECE POSSIBLE LOT NUMBERS. LOTS #2-004; 11-004 AND 18-004. SECTION H6, HEALTH EFFECT-CLINICAL CODE: 4581, IS TO CAPTURE INCISION ENLARGEMENT. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. 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 THE 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 · 0

    IT WAS REPORTED THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS TOO THICK FOR THE CARTRIDGE. IT WAS NOTICED TO BE SCRATCHED AFTER IT WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE INCISION WAS ENLARGED AND THE IOL WAS REMOVED AND REPLACED WITH THE SAME MODEL. REPORTEDLY, THERE WERE NO DELAYS IN THE PROCEDURE. THE JNJ OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS ALLOWED TO ACCLIMATIZE TO OPERATING ROOM TEMPERATURE. THIS EVENT ENTAILS ONE PATIENT WITH 3 ATTEMPTS. THE FOURTH IOL WAS SUCCESSFULLY IMPLANTED. THEIR TECHNICIAN HAS DECADES OF EXPERIENCE. THE TECHNICIAN FELT THE IOLS WERE ALMOST TOO BIG FOR THE CARTRIDGE. THEREFORE, THE TECHNICIAN WAS APPREHENSIVE TO FOLD IT. THREE DIFFERENT IOLS AND EMERALD CARTRIDGES WERE USED. THE CARTRIDGES WERE FROM THE SAME LOT INCLUDING THE ONE USED TO COMPLETE THE PROCEDURE. THE HANDPIECES WERE FROM DIFFERENT LOTS. THE CUSTOMER MENTIONED THAT THE HANDPIECES WERE SUCCESSFULLY USED IN OTHER CASES. ONLY THIS EVENT HAD PATIENT CONTACT. THROUGH FOLLOW-UP THE CUSTOMER REITERATED THAT THE COMPLAINT IS AGAINST THE IOL. THERE WERE NO ADDITIONAL COMPLICATIONS SUCH AS CAPSULE TEAR, UNPLANNED VITRECTOMY, OR SUTURES. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821910 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40M 05050474501836

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male