BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 19986812 · Received August 14, 2024

    Report

    Report Number
    3012236936-2024-000211
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Report Date
    September 9, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731967
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW FILE ASSESS AS NOT REPORTABLE AS THE LENS BOX WAS SPILLED/STICKY SUBSTANCE (NOT THE INNER CONTENTS); THEREFORE, NO STERILITY BREACH. HENCE FILE IS NO LONGER REPORTABLE. THEREFORE, THIS EVENT IS ASSESSED AS NOT REPORTABLE. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MFR REPORT NUMBER 3012236936-2024-0002113.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5, A6: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION B3: DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE SUSPECT LENS AND FOUND THE FOLDING CARTON WAS RECEIVED WITH A BROWN STAIN ON THE LABEL AND FOLDING CARTON. THE FOLDING CARTON WAS OPENED FOR EVALUATION AND FOUND THE STERILIZATION POUCH WAS SEALED AND SHOWED NO STAINING. THE HANDPIECE WAS SEATED CORRECTLY IN THE HANDPIECE TRAY. THE LENS WAS INSPECTED THROUGH THE LENS MODULE AND APPEARED TO HAVE NO ISSUES. NO ADDITIONAL ISSUES WERE IDENTIFIED. NO FURTHER EVALUATION WAS PERFORMED. BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A DIB00 30.0, APPEARED TO BE DAMAGED WITH SOMETHING SPILLED ON IT AND DRIED. THERE WAS NO PATIENT CONTACT. FURTHER INFORMATION SUGGESTS THAT IT LOOKED LIKE A CAN OF SODA WAS SPILLED ON THE LENS. ADDITIONALLY, THE OUTER SHIPPING BOX APPEARED TO HAVE BEEN REPACKAGED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361714 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown