BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2924854 · Received January 17, 2013

    Report

    Report Number
    1119421-2013-00029
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 17, 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
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. THERE WAS NO CONTACT INFORMATION PROVIDED; THEREFORE, FOLLOW-UP COULD NOT BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER POSTED ON A SOCIAL MEDIA WEBSITE THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE/SHE IS EXPERIENCING DIFFICULTY WITH NIGHT VISION, GLARE AND BLURRED VISION. THERE WAS NO CONTACT INFORMATION PROVIDED; THEREFORE, FOLLOW-UP COULD NOT BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26245 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH. LTD./ HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other