BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 20441418 · Received October 14, 2024

    Report

    Report Number
    3012236936-2024-000276
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 11, 2024
    Report Date
    November 18, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531734
    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 A2, A4, A5 AND A6: UNKNOWN/ NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED AND REPLACED IN THE INITIAL SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED AND REPLACED IN THE INITIAL SURGERY. SECTION E1: REPORTER: TELEPHONE NUMBER: (B)(6) SECTION H3: 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

    CORRECTION: H6: ADVERSE EVENT PROBLEM: CODE '3221 - NO FINDINGS AVAILABLE' UPDATED TO '213 - NO DEVICE PROBLEM FOUND' UPON FURTHER REVIEW, CARTRIDGE IS ADDED AS A CONCOMITANT PRODUCT FOR THE INTRAOCULAR LENS PRODUCT. THIS FOLLOW-UP #1 REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTED DATA UNDER MFR REPORT NUMBER 3012236936-2024-0002760. SEPARATE REPORT IS SUBMITTED FOR THE CARTRIDGE PRODUCT RECORD. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN DOCTOR DID THE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) INSERTION, THERE WAS RESISTANCE, WHEN PUSHED INTO THE EYE. IOL WAS FULLY INSERTED INTO PATIENT'S EYE. THERE WAS A DEFECT AT THE HAPTIC OPTIC JUNCTION, THEREFORE DOCTOR REMOVED THE IOL DURING THE SAME PROCEDURE AND REPLACED IT WITH BACKUP IOL. NO FURTHER INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810151 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male 1MTEC30 CARTRIDGE (LOT NUMBER: UNKNOWN)