BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 6084537 · Received November 7, 2016

    Report

    Report Number
    9612169-2016-00143
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Report Date
    April 12, 2017
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LENS REMAINS IMPLANTED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE IOL MET RELEASE CRITERIA. ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    A VIDEO OF A SURGICAL PROCEDURE WAS PROVIDED FOR REVIEW. AT THE END OF AN UNEVENTFUL CATARACT SURGERY 4 VACUOLES ARE OBSERVED AT THE 6 O'CLOCK LOCATION, APPARENTLY IN THE IOL BODY, RESPECTING THE VISUAL AXIS. UNABLE TO DETERMINE ORIGIN OR EXACT LOCATION OF APPARENT VACUOLES. NO DETERMINATION COULD BE MADE FROM THE VIDEO PROVIDED BY THE CUSTOMER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT WHEN AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, IT WAS NOTED TO HAVE MICROVACUOLES. THEY WERE NOT IN THE VISUAL AXIS, SO THE LENS WAS LEFT IMPLANTED WHERE IT REMAINS. THERE IS NO INDICATED PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734952 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21156001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other