BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3820718 · Received May 7, 2014

    Report

    Report Number
    1119421-2014-00322
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE REPORTER DID NOT PROVIDE ANY CONTACT INFO, THEREFORE, F/U WAS NOT ABLE TO BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED BLURRY DISTANCE VISION IMMEDIATELY AFTER HAVING THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE LEFT EYE. HOWEVER, HER NEAR VISION IMPROVED. SHE EXPECTED THE DISTANCE VISION TO BE IMPROVED AND SHE IS NOW HAVING TROUBLE SEEING BEYOND THE DISTANCE OF ONE FOOT. SHE CANNOT WATCH TELEVISION AND SHE IS CONCERNED THAT SHE WILL HAVE TO WEAR GLASSES TO IMPROVE HER DISTANCE VISION. SHE DISCUSSED THIS WITH HER SURGEON ON HER FIRST POSTOPERATIVE DAY VISIT AND HE INFORMED HER THAT SHE HAD SOME SWELLING AND RECOMMENDED THAT SHE WAIT ABOUT THREE WEEKS BEFORE EVALUATING THE OUTCOME. THE REPORTER DID NOT PROVIDE ANY CONTACT INFO, THEREFORE, F/U WAS NOT ABLE TO BE CONDUCTED. SHE DECLINED TO PROVIDE FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276680 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 12277092

    Patients

    Seq Age Sex Outcome Treatment
    1 Other