BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2844578 · Received November 16, 2012

    Report

    Report Number
    1119421-2012-01439
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    January 1, 2012
    Report Date
    October 20, 2012
    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. THERE WERE NO OTHER COMPLAINTS REPORTED IN THE LOT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT REPORTED SEEING HALOS AT NIGHT CAUSING HER TO FEEL UNSAFE WHEN DRIVING. THE PATIENT ALSO REPORTED THAT SHE NEEDS TO WEAR SUNGLASSES "ALL THE TIME" DUE TO GLARE. THE SURGEON INDICATED THAT THE LENS IS SLIGHTLY DECENTERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH. LTD./ HUNTINGTON SN6AD1 10932632

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other