BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 852248 · Received May 11, 2007

    Report

    Report Number
    1119421-2007-00184
    Event Type
    Injury
    Date Received
    May 11, 2007
    Date of Event
    October 27, 2006
    Report Date
    April 11, 2007
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    CONSUMER REPORTED HER NEAR VISION IS WORSE FOLLOWING BILATERAL CATARACT EXTRACTION AND INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADD'L INFO RECEIVED FROM FACILITY REPORTS THE PT HAD BILATERAL PCO NOTED TWO MONTHS FOLLOWING SURGERY. A YAG CAPSULOTOMY WAS DONE ONE HER LEFT EYE IN 2006. THE PT REFUSED TO HAVE A YAG CAPSULOTOMY DONE ON HER RIGHT EYE. PT OUTCOME AND PROGNOSIS WERE REPORTED AS "UNK". MFR'S REPORT NUMBER: 1119421-2007-00182 (RIGHT EYE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60D3 976656

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention PREDFORTE