BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2630897 · Received June 21, 2012

    Report

    Report Number
    1119421-2012-00800
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    January 1, 2012
    Report Date
    May 22, 2012
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADD'L INFO HAS BEEN REQUESTED BY PHONE BY PHONE, FAX, AND MAIL ON 05/25/2012 AND 05/29/2012. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. 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 12082095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other