BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 4173980 · Received October 1, 2014

    Report

    Report Number
    1119421-2014-00747
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 16, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED APPROXIMATELY SIX YEARS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT, THE LENS WAS EXCHANGED. THE PATIENT EXPERIENCED GLARE AND HALOS. IN A FOLLOW UP, THE SURGEON REPORTED THE INITIAL CATARACT SURGERY HAD BEEN PERFORMED BY ANOTHER SURGEON. THE LENS WAS EXCHANGED DUE TO THE GLARE AND HALOS. THE OUTCOME OF THE EVENT IS REPORTED TO BE RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611548 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12072025

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention