BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 17864749 · Received October 3, 2023

    Report

    Report Number
    3012236936-2023-02463
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 6, 2023
    Report Date
    July 25, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474502154
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4 AND A5: UNKNOWN/NOT PROVIDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. SECTION D6A: IMPLANT DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D6B: EXPLANT DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: OTHER 81: THE DEVICE WAS NOT 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    PRODUCT INFORMATION WAS INADVERTENTLY SUBMITTED INCORRECTLY IN THE INITIAL REPORT. THEREFORE, THE FOLLOWING FIELDS ARE BEING UPDATED TO REFLECT THE CORRECT INFORMATION: ADDITIONAL INFORMATION: SECTION D1 - BRAND NAME: SENSAR IOL. SECTION D2B - DEVICE PRODUCT CODE: HQL. SECTION D4 ADDITIONAL DEVICE INFORMATION. MODEL NUMBER: AR40E. CATALOG NUMBER: AR40E00225. SERIAL NUMBER: (B)(6). EXPIRATION DATE: MAY 18, 2027. PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER: (B)(4). SECTION H4 - DEVICE MANUFACTURE DATE: MAY 19, 2022. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A PLANNED SCLERAL FIXATED SECONDARY INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE IN THEIR LEFT EYE. WHEN THE IOL WAS INTRODUCED INTO THE ANTERIOR CHAMBER OF THE PATIENT'S EYE, THE TRAILING HAPTIC BROKE. THE IOL WAS REMOVED AND REPLACED WITH A NON-JOHNSON&JOHNSON LENS. THERE WERE MEDICATIONS PRESCRIBED AS PART OF STANDARD OF CARE, AND PLANNED SUTURES WERE PLACED. ACCOUNT INDICATED THAT THE PATIENT WAS WELL POST-OPERATIVELY AND VISION WAS OKAY. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741058 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474502154

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female