BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2400974 · Received January 4, 2012

    Report

    Report Number
    1119421-2011-01599
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    October 1, 2011
    Report Date
    December 5, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED 12/6/2011 AND 12/7/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCING GLARE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE STATED THERE IS "POSTERIOR CAPSULE OPACIFICATION (PCO) ON THE ANTERIOR SURFACE AND POSSIBLY THE POSTERIOR SURFACE OF THE IOL." 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 12064886

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other