BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 23138172 · Received September 24, 2025

    Report

    Report Number
    3012236936-2025-000242
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    April 14, 2025
    Report Date
    January 20, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: NOVEMBER 5, 2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED, REVEALING THAT THE LENS WAS CUT AND HAD SURFACE AND EDGE DAMAGE. ONE HAPTIC WAS ALSO OBSERVED TO BE BENT. THE COMPLAINT ISSUE "POSITIONING ISSUE" WAS NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: A REVIEW REVEALED THAT ALTHOUGH THE INITIAL MDR INDICATED THE DEVICE WAS NOT AVAILABLE FOR RETURN, THE DEVICE WAS RETURNED AND EVALUATED. THAT EVALUATION WAS INCLUDED IN SUPPLEMENTAL MDR REPORT #2 BUT THE CLARIFICATION WAS NOT EXPLAINED IN THAT REPORT. THIS SUPPLEMENTAL MDR REPORT IS TO INDICATE THAT INFORMATION. THE FOLLOWING CODE WHICH WAS ENTERED IN THE INITIAL MDR REPORT IS NO LONGER APPLICABLE: SECTION H6: DEVICE CODE: 4115 - DEVICE DISCARDED ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTICED THAT AN INCORRECT DATE (SEP 8, 2025) WAS INADVERTENTLY ENTERED IN SECTION ¿G3¿ OF THE INITIAL MDR REPORT WHICH IS INCORRECT. THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED IS SEP 5, 2025. THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION G3 DATE RECEIVED BY MANUFACTURER: SEP 5, 2025. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A4: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION A5: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION A6: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. 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 AS IT WAS DISCARDED; 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. SECTION H6: HEALTH EFFECT - IMPACT CODE: 4625 - INCISION ENLARGEMENT SECTION H6- HEALTH EFFECT - CLINICAL CODE 4581: NO CODE AVAILABLE (INCISION ENLARGEMENT). ATTEMPTS HAVE BEEN MADE TO OBTAIN THE INFORMATION; HOWEVER, NO RESPONSE WAS RECEIVED. 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 (IOL) WAS INITIALLY INSERTED INTO THE EYE AND FULLY ENTERED THE CAPSULAR BAG. DUE TO THE IOL DISLOCATION, THE LENS WAS CUT OUT/REMOVED AND A NEW LENS WAS INSERTED. THIS REQUIRED AN INCISION ENLARGEMENT. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. IT WAS CONFIRMED THAT NO DAMAGE NOTED TO THE COMPLAINT DEVICE DURING PREPARATION. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439597 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male EMERALD CARTRIDGE.