BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1821701 · Received August 27, 2010

    Report

    Report Number
    1119421-2010-00954
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 29, 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
    TX, 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. ADD'L INFO WAS REQUESTED ON 07/29/2010 AND 08/03/2010 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE RECEIVES ON 08/03/2010. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 08/05/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "BLURRY VISION" (BLURRED VISION). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER'S HUSBAND REPORTED THAT HIS WIFE IS EXPERIENCING BLURRY VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. MEDICAL RECORDS WERE RECEIVED AND INDICATED THAT AT FIVE WEEKS POSTOPERATIVELY, SHE REPORTED, HER VISION IS "STILL VERY BLURRY AT DISTANCE, CAN'T FOCUS AT DISTANCE AND NEAR" AND THAT EVERY TIME SHE BLINKS IT "CHANGES HER VISION". IN A F/U, THE SURGEON REPORTED THAT IN HIS OPINION, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. HE ALSO REPORTED NUMEROUS OCULAR AND NON-OCULAR MEDICAL HISTORIES FOR THIS PT. THE PT'S ISSUE RESOLVED WITH PRESCRIPTION GLASSES. 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 SN6AT5 10982118

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other DELIVERY SYSTEM| MIRALAX| SEABIOTICS| VISCOELASTIC| FISH OIL| ADVIL| METAMUCIL| ZERGERID| LIPITOR| CHLOR-TRIMENTON| CALTRATE