BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1943518 · Received December 2, 2010

    Report

    Report Number
    1119421-2010-01334
    Event Type
    Other
    Date Received
    December 2, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 2, 2010
    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
    FL, 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 HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER FOR THE FELLOW EYE. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE WAS NOTICING HALOS AT NIGHT WITH THE RIGHT EYE WHEN LOOKING AT LIGHTS. HE HAS ALSO BEEN SEEING LONG STREAKS OF LIGHTS AT NIGHT WHEN LOOKING AT HEADLIGHTS, STREET LIGHTS AND STOP LIGHTS. THE CONSUMER REPORTED HE HAD A HISTORY OF DRY EYES, HYPERTENSION, HYPERCHOLESTEROLEMIA AND ANEMIA (PRE-EXISTING). AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. 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 SN6AT3 10978691

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LIPITOR| METANX DAILY MEDICATIONS| DILITIAZEM| IRON| LISINOPRIL| ASPIRIN| ARTIFICIAL TEARS| HYDROCHLOROTHIAZIDE