BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 18044406 · Received October 31, 2023

    Report

    Report Number
    3012236936-2023-02638
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    October 5, 2023
    Report Date
    December 28, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474652729
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. DATE RETURNED TO MANUFACTURER: NOV 21, 2023 SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION REVEAL THAT THE COMPLAINT LENS WAS RECEIVED CUT INTO FOUR PIECES. THE LENS WAS CLEANED AND NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. CONCLUSION: THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND FURTHER ESCALATIONS ARE REQUIRED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS. 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 HAD VISUAL DISTURBANCE UNDER LOW LIGHT CONDITION AND THERE WERE SYMPTOMS OF STARBURST WHEN HE LOOKED AT LIGHT SOURCES. THE SURGEON EXPLANTED THE IENS AND EXCHANGED WITH OTHER REFRACTIVE IOL. THE VISUAL ACUITY PRE-OPERATIVE WAS 0.6 AND VISUAL ACUITY POST-OPERATIVE WAS 0.7. 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
    2199412 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. ZFR00V 05050474652729

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention| O