BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2771979 · Received October 2, 2012

    Report

    Report Number
    1119421-2012-01235
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    June 1, 2012
    Report Date
    August 29, 2012
    Manufacturer
    ALCON RESEARCH LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, SHE WAS SEEING BEAMS OF LIGHT IMMEDIATELY AFTER BLINKING WHILE SHE WAS WATCHING TELEVISION OR LOOKING AT A LAMP. SHE REPORTED THERE WAS A BRIGHT AREA SURROUNDED BY A DARK AREA. SHE ALSO REPORTED THAT SHE SEES LIGHT FANS WHEN THE LIGHT REACHES HER EYE LATERALLY. SHE NOTICES THESE EVENTS IN THE AFTERNOON AND EVENINGS. SHE SAW A SURGEON THAT WAS NOT THE IMPLANTING SURGEON AND SHE WAS TOLD THAT THIS PHENOMENA OCCURS WHEN THE PUPILS ARE DILATED AND WAS ADVISED TO USE MIOTIC EYE DROPS TO CONSTRICT HER PUPILS. SHE TRIED THE DROPS BUT SHE DOESN'T WANT TO USE THEM AGAIN. THE CONSUMER SAW THE IMPLANTING SURGEON 20 DAYS FOLLOWING THE IMPLANT SURGERY FOR THE LEFT EYE AND THE SURGEON NOTED A SLIGHT ROTATION OF THE IOL. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH LTD / HUNTINGTON SN6AT6 11071053

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other