BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 12686768 · Received October 24, 2021

    Report

    Report Number
    2020664-2021-07874
    Event Type
    Malfunction
    Date Received
    October 24, 2021
    Report Date
    April 6, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558229
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON FEB 18, 2022. SECTION H3. DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED. THE COMPLAINT ISSUE LENS DAMAGED COULD NOT BE CONFIRMED, BECAUSE THE LENS COULD NOT BE REMOVED FROM THE CARTRIDGE WITHOUT INTRODUCING DAMAGE TO THE LENS. THE COMPLAINT ISSUE STUCK IN THE CARTRIDGE COULD BE CONFIRMED; HOWEVER, IT MAY BE ATTRIBUTED TO AN INADEQUATE AMOUNT OF OVD USAGE, AND CANNOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING/DESIGN PROCESS AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. ADDITIONAL CONDITIONS WERE OBSERVED WITH THE RETURNED PRODUCT BUT THEY COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING/DESIGN PROCESS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, NO PATIENT CONTACT WITH PRODUCT. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, NO PATIENT CONTACT WITH PRODUCT. TELEPHONE NUMBER: (B)(6). THE INTRAOCULAR LENS (IOL) 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LENS DAMAGED AND STUCK IN CARTRIDGE WITH A MODEL PCB00 TECNIS ITEC PRELOADED DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584804 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown