BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2800911 · Received October 18, 2012

    Report

    Report Number
    1119421-2012-01290
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    June 22, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ALCON RESEARCH LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL 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 SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED BLURRY DISTANCE AND NEAR VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE STATED HE SEES RAYS AROUND LIGHTS, HAS HAD A CHANGE IN HIS GLASSES PRESCRIPTION OVER A 3 MONTH PERIOD AND ABOUT SIX MONTHS AGO HE WAS TOLD THAT IT WAS "BECAUSE HIS EYES ARE OLD." ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON SN60WF 12026917

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other