BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22522679 · Received July 16, 2025

    Report

    Report Number
    3012236936-2025-000195
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    June 18, 2025
    Report Date
    November 14, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636125
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW, IT WAS NOTICED THAT THERE WAS NO PATIENT CONTACT, THE PRODUCT WAS OPENED/NOT USED. THEREFORE, EVENT IS NO LONGER CONSIDERED REPORTABLE AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER 3012236936-2025-0001956. SECTION H6: HEALTH EFFECT - IMPACT CODE: 4644 IS NO LONGER APPLICABLE. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 1937 IS NO LONGER APPLICABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN/NOT REPORTED; IT IS UNKNOWN IF THE IOL HAD ANY PATIENT CONTACT OR IF IT WAS IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN/NOT REPORTED; IT IS UNKNOWN IF THE IOL HAD ANY PATIENT CONTACT OR IF IT WAS IMPLANTED. SECTION E1: FIRST/GIVEN NAME: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: 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 AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN 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 PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED, THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE (IOP) AND NEEDED TO RECEIVE MANITOL IV (INTRAVENOUS). NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151497 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention