BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1813641 · Received August 13, 2010

    Report

    Report Number
    1119421-2010-00894
    Event Type
    Other
    Date Received
    August 13, 2010
    Date of Event
    April 29, 2010
    Report Date
    July 14, 2010
    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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 07/14/2010 AND 07/15/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 07/16/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "GLARE; STREAK OF LIGHT" (VISUAL DISTURBANCES); "HALOS" (HALO). PRODUCT PROBLEM(S): "MILDLY TILTED" (MALPOSITION OF DEVICE [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER REPORTED SEEING A STREAK OF LIGHT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE REQUESTED AND RECEIVED. ACCORDING TO THE MEDICAL RECORDS, THE CONSUMER REPORTED SEEING A BRIGHT DIAGONAL LINE THAT WOULD GO AWAY WHEN THE LEFT EYE WAS COVERED. THE CONSUMER LATER REPORTED EXPERIENCING GLARE AND HALOS WITH NIGHT DRIVING. THE IOL WAS NOTED TO BE MILDLY TILTED AT A POSTOPERATIVE VISIT. THE CONSUMER REPORTED WHEN LOOKING AT A STREET LIGHT, SHE SEES AN "X" AND DIAGONAL LINE WHICH WAS WORSE IN HER LEFT EYE. POSTERIOR CAPSULE OPACIFICATION WAS OBSERVED. ADDITIONAL INFORMATION 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 IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT4 10974370

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other REFRESH DROPS