BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3231569 · Received July 15, 2013

    Report

    Report Number
    1119421-2013-00760
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 17, 2013
    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
    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 FOR FURTHER INVESTIGATION. THE CONSUMER DID NOT PROVIDE ANY CONTACT INFORMATION; THEREFORE, NO FOLLOW UP COULD BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    IN A SOCIAL MEDIA REPORT, A CONSUMER REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXCHANGED. THE CONSUMER STATED THAT THE SURGEON TARGETED MONOVISION DURING THE EXCHANGE PROCEDURE AND THIS CAME OUT PERFECTLY. THE CONSUMER REPORTED THE MONOVISION WAS WORKING BETTER THAN THE VISION WITH THE MULTIFOCAL LENS. THE CONSUMER STATED MOST TASKS COULD BE PERFORMED WITHOUT GLASSES. THE CONSUMER DID NOT PROVIDE ANY CONTACT INFORMATION; THEREFORE, NO FOLLOW UP COULD BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325998 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention