BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2885088 · Received December 19, 2012

    Report

    Report Number
    1119421-2012-01586
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 20, 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 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 REPORTER 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. NO CONTACT INFORMATION WAS PROVIDED BY THE CONSUMER; THEREFORE, FOLLOW-UP COULD NOT BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HAS HAD DECREASED QUALITY OF NEAR VISION WITH INCREASING BLURRINESS CAUSED BY CHANGES IN LIGHTING CONDITIONS. SHE SOUGHT A SECOND OPINION WHO FOUND NO FAULT WITH THE SURGERY AND COULD FIND NO REASONS FOR HER ISSUES, OTHER THAN INABILITY TO ADAPT TO THE LENSES. THE CONSUMER STATED SHE IS DISCUSSING POSSIBLE LENS EXCHANGES WITH HER CURRENT SURGEON. NO CONTACT INFORMATION WAS PROVIDED BY THE CONSUMER; THEREFORE, FOLLOW-UP COULD NOT BE CONDUCTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other