BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 774967 · Received October 20, 2006

    Report

    Report Number
    1119421-2006-00353
    Event Type
    Other
    Date Received
    October 20, 2006
    Report Date
    September 20, 2006
    Manufacturer
    ALCON LABORATORIES, INC / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    na
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS IMPLANT SURGERIES, A PATIENT IS COMPLAINING OF SEVERE GLARE AND HALOS. THE PATIENT REPORTS SEEING SEVEN CIRCLES AROUND LIGHT SOURCES IN THE EVENING. HER VISION DURING THE DAY AND FOR READING IS EXCELLENT WITH BCVA AND OS OF 20/20. THE ADAPTATION PROCESS WAS DISCUSSED WITH THE SURGEON DURING TELEPHONE FOLLOW-UP. HE HAS INDICATED THAT HE IS GOING TO CONTINUE TO MONITOR THIS PATIENT AND WILL LET US KNOW IF THERE ARE ANY FURTHER DEVELOPMENTS. MDR # 1110421-2006-00352---EYE #1. MDR # 1110421-2006-00353--EYE2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC / HUNTINGTON SN60D3 951563

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other