BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IOL

    MDR report key: 6683610 · Received July 1, 2017

    Report

    Report Number
    1119421-2017-00848
    Event Type
    Malfunction
    Date Received
    July 1, 2017
    Date of Event
    June 6, 2017
    Report Date
    July 1, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    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

    PRODUCT EVALUATION: NO PRODUCTS HAVE BEEN RETURNED FOR ANALYSIS; THE LENSES REMAINS IMPLANTED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT FOLLOWING AN UNSPECIFIED NUMBER OF CATARACT REMOVAL WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, HE NOTICED A FEATHERING-LIKE APPEARANCE ON THE IOLS. THE SURGEON FEELS THAT THE ISSUE IS MORE NOTICEABLE IN IOL POWERS GREATER THAN 22.0D (DIOPTERS), AS IOLS WITH POWERS GREATER THAN 22.0D HAVE A FAINT CREASE IN THE IOL WHICH IS STILL NOTICEABLE THE DAY AFTER SURGERY. HE FEELS THAT IT IS IN THIS CREASE THAT THE EPITHELIAL CELLS MIGRATE, ON THE ANTERIOR ASPECT OF THE IOL. THE SURGEON NOTED THAT HE POLISHES THE ANTERIOR CAPSULE FOR EACH PATIENT. THERE HAS BEEN NO HARM TO PATIENTS REPORTED, AND THERE HAS BEEN NO ACTION TAKEN TO MITIGATE THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463942 ACRYSOF IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. - HUNTINGTON ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other