BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 23136751 · Received September 24, 2025

    Report

    Report Number
    3012236936-2025-000239
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    August 28, 2025
    Report Date
    November 3, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTICED THAT THE IMPACT CODE 4625 AND CLINICAL CODE 4581 FOR THE REPORTED INCISION ENLARGEMENT WERE INADVERTENTLY OMITTED FROM THE INITIAL MDR REPORT. THE INFORMATION HAS BEEN CAPTURED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION H6: HEALTH EFFECT - IMPACT CODE: 4625 - ADDITIONAL SURGERY (INCISION ENLARGED) SECTION H6: HEALTH EFFECT - CLINICAL CODE: 4581: NO CODE AVAILABLE (INCISION ENLARGED) ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME SURGERY. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (AR40E) WAS FOLDED AND INSERTED PERFECTLY INTO THE PATIENT¿S RIGHT EYE. THE DOCTOR NEEDED TO DO SOME MANIPULATION IN THE ANTERIOR CHAMBER AND THE HAPTIC DETACHED. THIS REQUIRED AN UNPLANNED INCISION ENLARGEMENT. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH A LENS OF THE SAME MODEL AND DIOPTER. NO OTHER SURGICAL INTERVENTIONS REQUIRED AND NO MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS PRESCRIBED. THE PATIENT'S POSTOPERATIVE STATUS IS CURRENTLY UNKNOWN. IT WAS NOTED THAT DIRECTION FOR USE WAS FOLLOWED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598808 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male