BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 11407109 · Received March 3, 2021

    Report

    Report Number
    1119421-2021-00474
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 11, 2021
    Report Date
    March 15, 2021
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380655093153
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUS REPORT SUBMITTED FOR THIS EVENT CONTAINED AN ERROR IN H.1. - ¿SUMMARY REPORT¿ WAS INADVERTENTLY SELECTED. AFTER A RECENT SYSTEMS UPDATE, A SYSTEM ERROR CAUSED THE INADVERTENT ADDITIONAL SELECTION OF ¿SUMMARY REPORT¿ IN H.1. ON A SELECT NUMBER OF REPORTS. THE ERROR, WHICH WAS LIMITED ONLY TO THE H.1. FIELD, WAS PROMPTLY IDENTIFIED AND QUICKLY RECTIFIED. CORRECTION SMDRS ARE BEING FILED FOR THE IMPACTED REPORTS. THIS SMDR IS CORRECTING THAT ERROR FOR THIS EVENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED. SOLUTION IS DRIED ON THE LENS. HAPTIC AND OPTIC DAMAGE WAS OBSERVED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. QUALIFIED ASSOCIATED PRODUCTS WERE PROVIDED. THE REPORTED CRACK WAS OBSERVED. ALL LENSES ARE 100% INSPECTED FOR COSMETIC ATTRIBUTES AND THE DAMAGE EXHIBITED BY THE RETURNED COMPLAINT SAMPLE WOULD NOT HAVE MET RELEASE CRITERIA. BASED ON OUR OBSERVATION, AND THE REVIEW OF MANUFACTURING RECORDS, IT CAN BE REASONABLY CONCLUDED THAT THE DAMAGE IS NOT MANUFACTURING RELATED. DUE TO THE PRESENCE OF SURGICAL SOLUTION AND THE CONDITION OF THE RETURNED SAMPLE, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT PROCEDURE, THE INTRAOCULAR LENS (IOL) WAS CRACKED AFTER INSERTION IN THE PATIENT'S RIGHT EYE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP IOL. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304183 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF 12739451 00380655093153

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR DISCOVISC OVD| MONARCH CARTRIDGE| MONARCH INJECTOR