BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 4193241 · Received October 21, 2014

    Report

    Report Number
    1119421-2014-00832
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    January 1, 2013
    Report Date
    September 21, 2014
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT HAVE BEEN REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDED A LOT NUMBER OR ANY IDENTIFIED TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. THE REPORTER DID NOT PROVIDE CONTACT INFO FOR THE HEALTHCARE PROFESSIONAL; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, HE HAS EXPERIENCED "EXTREME" GLARE AT NIGHT WHILE DRIVING, LOOKING AT STREET LIGHTS AND LIGHTS FROM OTHER CARS. THE CONSUMER STATED HIS OPHTHALMOLOGIST RECOMMENDED GLASSES; HOWEVER, "THEY DID NOT HELP." THE REPORTER DID NOT PROVIDE ANY CONTACT INFO FOR THE HEALTHCARE PROFESSIONAL; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE CONSUMER. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669128 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other