BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2800813 · Received October 17, 2012

    Report

    Report Number
    1119421-2012-01300
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    January 1, 2012
    Report Date
    September 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
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    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 INFO. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE HAS A CONSTANT PAIN WHEN WORKING ON THE COMPUTER, VERTIGO AND A BURNING/STRAINED SENSATION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE STATED HER VISION IS BLURRED WITH GLASSES WHICH INTERFERES WITH HER READING. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 11019311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other