BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2023645 · Received March 4, 2011

    Report

    Report Number
    1119421-2011-00229
    Event Type
    Other
    Date Received
    March 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 4, 2011
    Manufacturer
    ALCON RESEARCH. LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO SERIAL/LOT NUMBER OR SAMPLE WAS PROVIDED BY THE CUSTOMER. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. ADDITIONAL INFO WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED A PT WITH A TWO LINE REDUCTION IN VISUAL ACUITY ONE YEAR FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE OPHTHALMOLOGIST REPORTED HE OBSERVED THE IOL WAS "OPACIFIED" BY BIOMICROSCOPY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH. LTD. / HUNTINGTON SN60WF NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other