BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 8686238 · Received June 11, 2019

    Report

    Report Number
    1119421-2019-00852
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    April 30, 2019
    Report Date
    September 19, 2019
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION: THE LENS WAS RETURNED. ONE HAPTIC IS PRESSED AGAINST A POST OF THE LENS CASE AND IS TORN ON THE GUSSET EDGE. THE LENS IS TILTED IN THE LENS CASE WELL AREA AND THE OPTIC IS BROKEN/TORN AGAINST A POST OF THE LENS CASE. THERE IS NO VISCOELASTIC PRESENT ON THE COMPLAINT LENS. THE COMPLAINT LENS WAS MALPOSITIONED IN THE LENS CASE AND LENS DAMAGE WAS OBSERVED. DUE TO THE ABSENCE OF CLINICAL SOLUTION ON THE RETURNED SAMPLE THE ROOT CAUSE IS POTENTIALLY MANUFACTURING RELATED. IF THE LENS BECOMES MISALIGNED IN THE LENS CASE LENS DAMAGE MAY OCCUR. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS CROOKED, DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480275 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON SV25T0 12581732

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR DUOVISC