BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 2903302 · Received December 14, 2012

    Report

    Report Number
    1119421-2012-01574
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HE HAS OBSERVED MICROVACUOLES ON THE LENSES OF HIS PTS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE HAS OBSERVED THIS ISSUE WITHIN THE PAST SIX MONTHS. THE SURGEON DID NOT REPORT ANY SYMPTOMS EXPERIENCED BY THE PTS. NO FURTHER INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60AC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1