BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL

    MDR report key: 11292874 · Received February 8, 2021

    Report

    Report Number
    1119421-2021-00240
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    February 1, 2021
    Report Date
    March 17, 2021
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    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

    CORRECTED INFORMATION PROVIDED IN H.10. THE INITIAL MDR 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 · 0

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

    Additional Manufacturer Narrative · 0

    THE LENS WAS RETURNED FOR EVALUATION. SOLUTION AND BLOOD ARE DRIED ON THE LENS. THE LENS IS CUT IN HALF. ONE HALF IS SPLIT IN TWO AREAS. THE OTHER HALF OF THE OPTIC HAS TWO DEEP SCRATCHES, ONE NEAR THE EDGE OF THE OPTIC ON THE POSTERIOR SIDE AND ONE ON THE POSTERIOR SIDE OF THE HAPTIC. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. THE CARTRIDGE AND HANDPIECE WAS NOT RETURNED FOR EVALUATION. THE REPORTED COMPLAINT OF LENS STUCK IN DELIVERY SYSTEM COULD NOT BE CONFIRMED DUE TO ONLY THE LENS BEING RETURNED. NO CARTRIDGE OR HANDPIECE WAS RETURNED. LENS DAMAGE WAS OBSERVED. 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).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE INCISION HAD TO BE ENLARGED BUT NO SUTURE WAS USED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, AN INTRAOCULAR LENS WOULD NOT CENTER AND THE PLUNGER OVERRODE THE LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195904 ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON DAT015 15066975

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention