BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 17070730 · Received June 6, 2023

    Report

    Report Number
    1119421-2023-01048
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 4, 2023
    Report Date
    June 6, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380655093221
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LENS WAS RETURNED ADHERED BY SOLUTION TO THE LENS CASE BASE (LID NOT RETURNED). SOLUTION WAS DRIED ON THE LENS. THE LENS WAS CLEANED WITH KLRP (KLOTHO-RELATED PROTEIN) FOR FURTHER EVALUATION. A DIMENSIONAL INSPECTION WAS CONDUCTED. THE LENS DIMENSIONS ARE ACCEPTABLE USING AN APPROVED (PLAN VIEW) TEMPLATE. ASSOCIATED CARTRIDGE WAS NOT RETURNED FOR EVALUATION. COMPLAINT AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE LENS DIMENSIONS ARE ACCEPTABLE (PLAN VIEW) USING AN APPROVED TEMPLATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS HAD TO BE LADED MULTIPLE TIMES AS IT WAS UNABLE O BE INSERTED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570428 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF 15504552 00380655093221

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female DUOVISC VISCOELASTIC SYSTEM| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C| MONARCH III IOL DELIVERY SYSTEM, INJECTOR