BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR IOL

    MDR report key: 21999010 · Received May 9, 2025

    Report

    Report Number
    3012236936-2025-000133
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    April 14, 2025
    Report Date
    October 24, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474502048
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A6: ACCOUNT REPORTED THE PATIENT RACE IS ASIAN/PACIFIC ISLANDER - JAPANESE, ASIAN/PACIFIC ISLANDER - KOREAN. HEALTH EFFECT - CLINICAL CODE 4581 USED FOR INCISION ENLARGEMENT HEALTH EFFECT - IMPACT CODE 4625 - ADDITIONAL SURGERY USED FOR THE UNPLANNED VITRECTOMY, SUTURES AND INCISION ENLARGEMENT 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 THE 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT THE FOLLOWING CODES (2199 & 4582) WERE INADVERTENTLY NOT ENTERED IN THE SECTION H6 OF THE INITIAL MDR REPORT. ALSO, IN SECTION "G2" THE BOX FOR "USER FACILITY " WAS INADVERTENTLY NOT SELECTED IN THE INITIAL MDR REPORT AND THE FIELDS (D8 & D9) WERE EITHER LEFT EMPTY OR NOT CORRECTLY SELECTED. THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION G2: REPORT SOURCE: USER FACILITY. SECTION D8: WAS THIS DEVICE SERVICED BY A THIRD PARTY SERVICER?: NO. SECTION D9: DEVICE AVAILABLE FOR EVALUATION? NO. THE FOLLOWING ADDITIONAL CODES WERE ADDED: SECTION H6: HEALTH EFFECT - IMPACT CODE: 2199 - NO HEALTH CONSEQUENCES OR IMPACT - THIS CODE WAS USED TO CAPTURE (INCOMPLETE TREATMENT/ APHAKIC). SECTION H6: HEALTH EFFECT - CLINICAL CODE: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS - THIS CODE WAS USED TO CAPTURE (INCOMPLETE TREATMENT/APHAKIC). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    ACCOUNT REPORTED THAT PATIENT HAD CATARACT PROCEDURE IN WHICH THE INTRAOCULAR LENS (IOL) WAS IMPLANTED. AFTER IOL WAS IMPLANTED THE DOCTOR NOTICED THE HAPTIC WAS KINKED AND HE PROCEEDED TO REMOVE THE LENS DURING THE SAME PROCEDURE. THE ACCOUNT INDICATED THERE WAS A CAPULAR TEAR AND THE PATIENT HAD A VITRECTOMY, SUTURES AND INCISION ENLARGEMENT. THE PATIENT WAS LEFT APHAKIC AND THE PLAN IS TO HAVE A SECONDARY LENS AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183403 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474502048

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention