BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2620761 · Received June 8, 2012

    Report

    Report Number
    1119421-2012-00742
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    February 27, 2012
    Report Date
    May 9, 2012
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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. ADDITIONAL INFO WAS REQUESTED ON 05/10/2012 AND 05/23/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 06/04/2012. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN UNEXPECTED POSTOPERATIVE OUTCOME FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. HE STATED THE IOL WAS REMOVED AND REPLACED WITH THE SAME MODEL LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12084822

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention PRED FORTE