BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL

    MDR report key: 16868690 · Received May 4, 2023

    Report

    Report Number
    9612169-2023-00347
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    January 20, 2023
    Report Date
    June 12, 2023
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652455930
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    BASED ON INFORMATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A SERIOUS INJURY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION/DIFFICULTY WITH VISION, CANNOT READ WELL AND HAVING TROUBLE WITH INTERMEDIATE VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH MONOFOCAL LENS. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT WAS ONLY CORRECTABLE TO DISTANCE 20/30, INTERMEDIATE 20/40. READING JIO. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ONE OF TWO.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING A 16.5 TORIC DIOPTER LENS WAS EXCHANGED FOR A 17.5 DIOPTER TORIC LENS DUE TO BLURRY VISION/DIFFICULTY WITH VISION, CANNOT READ WELL AND TROUBLE WITH INTERMEDIATE. THIS DOES NOT MEET CRITERIA FOR REPORTING BASED ON APPLICABLE MEDICAL DEVICE REGULATIONS. A LENS EXCHANGE FROM ONE POWER TO A DIFFERENT POWER IS AN ATTEMPT TO ADJUST OR FINE TUNE THE REFRACTIVE OUTCOME TRYING TO ACHIEVE A DESIRED TARGET WHEN THE INITIAL LENS CALCULATIONS DID NOT ACHIEVE THE INTENDED OUTCOME. THERE IS NO REPORTED DEFECT OR FAULT WITH THE LENS. IN THE SURGEON'S OPINION, PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AND PATIENT HAS OTHER OCULAR DIAGNOSIS HAS SUSPECTED THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859937 CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CCWET5 25298433 00380652455930

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention REPLACEMENT LENS: UNSPECIFIED TORIC MONOFOCAL LENS