BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 10770507 · Received November 2, 2020

    Report

    Report Number
    1119421-2020-01590
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Report Date
    December 18, 2020
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.10., H.3., H.6.,A ND H.10. TWO LENS CASE BASES WERE RETURNED. THE SERIALIZED LENS CASE LID WAS NOT RETURNED. THE LENS WAS RETURNED POSITIONED INCORRECTLY POSTERIOR SIDE UP IN ONE OF THE LENS CASE BASES. SOLUTION IS DRIED ON THE LENS. ONE HAPTIC IS BENT IN THE GUSSET AND DISTAL AREA PRESSED AGAINST THE POSTS OF THE LENS CASE. THE OPTIC IS PRESSED AGAINST A POST OF THE LENS CASE AND HAS A SCRAPE MARK ON THE POSTERIOR SIDE OF THE LENS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. THE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED OF ¿DEFECTIVE¿. THE SPECIFIC LENS ISSUE WAS NOT SPECIFIED. DAMAGE TO THE LENS WAS OBSERVED. WHILE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE LENS DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT 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 · 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 HEALTH PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) IMPLANT WAS DEFECTIVE. THE TIMING OF THE EVENT AND PATIENT IMPACT ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240942 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT00 15038263

    Patients

    Seq Age Sex Outcome Treatment
    1