BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3062808 · Received April 11, 2013

    Report

    Report Number
    1119421-2013-00384
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 1, 2012
    Report Date
    March 15, 2013
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY FAX AND MAIL. ADDITIONAL INFORMATION HAS BEEN PROVIDED; HOWEVER, A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH POOR VISION DUE TO THE LENS WAS DECENTERED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPORTING THE MULTIFOCAL LENS WAS EXCHANGED TO A MONOFOCAL IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155527 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN6AD1 10900847

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention