BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 13749344 · Received March 12, 2022

    Report

    Report Number
    1119421-2022-00455
    Event Type
    Malfunction
    Date Received
    March 12, 2022
    Date of Event
    January 6, 2022
    Report Date
    April 26, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652250382
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NO OTHER COMPLAINTS IN THE LOT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER INDICATED THE USE OF QUALIFIED ASSOCIATED PRODUCTS. BASED ON THE INFORMATION PROVIDED, THE EVENT DOES NOT APPEAR TO BE RELATED TO THE PRODUCT. THE PRODUCT WAS NOT RETURNED TO EVALUATE. INFORMATION WAS PROVIDED THAT IN THE SURGEON'S OPINION, THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. IN THE SURGEON'S OPINION, THE EVENT WAS CAUSED BY "IMPROPER LOADING OF THE LENS BY THE SCRUB TECH." THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SCRATCH ON LENS NOTED AFTER IT WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, IN THE SURGEON OPINION IMPROPER LOADING OF THE LENS BY THE SCRUB TECH WAS THE CAUSE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226319 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON SN6AT4 15182969 00380652250382

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DISCOVISC| MONARCH , CARTRIDGE D| MONARCH INJECTOR