BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2844559 · Received November 16, 2012

    Report

    Report Number
    1119421-2012-01405
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    August 26, 2012
    Report Date
    October 18, 2012
    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
    NY, US
    Reporter Occupation
    OTHER

    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. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN INTRAOCULAR LENS WAS EXCHANGED DUE TO THE PATIENT HAVING REDUCED READING AND A SENSE OF BEING OF BALANCE. IN A FOLLOW UP, THE SURGEON REPORTED THE PATIENT WAS EXPERIENCING HALOS WITH POINT SOURCE LIGHTS AND BLURRINESS RELATED TO A MILD HYPEROPIC OUTCOME. THE LENS WAS EXCHANGED FOR THE SAME MODEL, DIFFERENT POWER IOL. THE SURGEON REPORTED THAT FOLLOWING THE EXCHANGE, THE PATIENT HAD IMPROVED VISION WITH NO HALOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH. LTD./ HUNTINGTON SN6AD1 12153100

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention DUOVISC| HANDPIECE| UNK MONARCH CARTRIDGE