BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 4122308 · Received September 18, 2014

    Report

    Report Number
    1119421-2014-00734
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE DIOPTER OF THE REPLACEMENT LENS IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT. ADDITIONAL INFORMATION WAS REQUESTED BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A MATERIALS MANAGER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT HAD A REFRACTIVE LENS ERROR. THE LENS WAS EXCHANGED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579074 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12290811

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention