BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 12927439 · Received December 3, 2021

    Report

    Report Number
    9612169-2021-00282
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 5, 2021
    Report Date
    February 4, 2022
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380655093184
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    FOUR IMAGES WERE SUBMITTED AND REVIEWED. BOTH OD AND OS SLIT LAMP IMAGES ARE OPTIC SECTIONS ILLUMINATING THE CENTER OF THE IOLS THROUGH DILATED PUPILS. THE IMAGES SHOW WHAT APPEAR TO BE DIFFUSE REFRACTILE BODIES WITHIN THE IOLS. THE CORRESPONDING OD AND OS PENTACAM IMAGES ALSO DEMONSTRATE THE PRESENCE OF THE REFRACTILE BODIES APPEARING TO BE WITHIN THE BULK OF THE IOLS CONSISTENT WITH MICROVACUOLES SUCH AS ASSOCIATED WITH GLISTENINGS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A MEDICAL ENGINEER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND OTHER VISUAL SIDE EFFECTS. THE SLIT LAMP IMAGES AND THE PENTACAM IMAGES SHOW GLISTENING'S. DIAGNOSED WITH GLIMMER VISION, SPECIAL ON THE LEFT EYE. THE PATIENT ISSUE WAS NOT RESOLVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED AND STATED THAT, EXPLANATION HAS NOT YET BEEN PERFORMED AND ACCORDING TO THE PATIENT, THEY HAVE NOT YET PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821547 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21136296 00380655093184

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male