BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ VIVITY EXTENDED VISION IOL

    MDR report key: 11423013 · Received March 5, 2021

    Report

    Report Number
    1119421-2021-00490
    Event Type
    Malfunction
    Date Received
    March 5, 2021
    Date of Event
    February 16, 2021
    Report Date
    April 29, 2021
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652421218
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE LENS WAS RETURNED IN THE LENS CASE. VISCOELASTIC IS OBSERVED ON THE LENS. ONE HAPTIC IS BROKEN-GUSSET AREA NOT RETURNED. THE REMAINING HAPTIC IS BROKEN-DISTAL AREA, BROKEN PORTION IN LENS CASE. THE OPTIC HAS BEEN CUT INTO TWO PIECES RETURNED ADHERED TO EACH OTHER. THE LENS WAS CLEANED WITH LPHSE FOR FURTHER EVALUATION. THE TWO PIECES WERE SEPARATED. ONE OPTIC PORTION HAS A GOUGE/DIVOT WITH MATERIAL REMOVED ON THE ANTERIOR SURFACE. THERE ARE SMALL V-SHAPED CRACKS AT THE START OF THE DAMAGED AREA. THIS DAMAGE MATCHES THE AREA OBSERVED IN THE PROVIDED PHOTO. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. A QUALIFIED CARTRIDGE WAS INDICATED. THE LENS WAS RETURNED AND DAMAGE WAS OBSERVED. THE DAMAGE WAS NOT OBSERVED UNTIL AFTER THE LENS WAS IMPLANTED. IT CANNOT BE VERIFIED THAT THE PRODUCT WAS DAMAGED BEFORE USE. ALL LENSES ARE 100% INSPECTED FOR COSMETIC ATTRIBUTES AND THE DAMAGE EXHIBITED BY THE RETURNED COMPLAINT SAMPLE WOULD NOT HAVE MET ALCON¿S 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).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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

    EVALUATION SUMMARY: COMPLAINT HISTORY RECORDS WERE REVIEWED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UPON IMPLANTING AN INTRAOCULAR LENS (IOL), THERE WAS A GREY DEPOSIT IN THE CENTER OF THE IMPLANTED LENS. THERE WAS NO REPORTED PATIENT HARM. DURING A FOLLOW UP CHECK, THE SURGEON DID NOT SEE THE DEPOSIT IN THE LENS ANY LONGER. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320498 ACRYSOF IQ VIVITY EXTENDED VISION IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DFT015 15060141 00380652421218

    Patients

    Seq Age Sex Outcome Treatment
    1 MONARCH III D CARTRIDGES| MONARCH III IOL DELIVERY SYST| OVD: BIOLON