BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1912885 · Received November 11, 2010

    Report

    Report Number
    1119421-2010-01240
    Event Type
    Other
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 12, 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
    PA, US
    Reporter Occupation
    OTHER

    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 10/14/2010 AND 10/26/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. MEDICAL RECORDS WERE REC'D ON 10/22/2010. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE REQUESTED AND REC'D. ACCORDING TO THE MEDICAL RECORDS, THE PT HAD A HISTORY OF VITREAL FLOATERS, NON-NEOVASCULAR MACULAR DEGENERATION, LATTICE RETINAL CHANGES, CONJUNCTIVAL CYST, BLEPHARITIS, DIABETES, HYPERTENSION, HYPER CHOLESTEROLEMIA, AND DEGENERATIVE JOINT DISEASE (PRE-EXISTING). ON THE FIRST POSTOPERATIVE DAY, THE PT NOTED LIGHT SENSITIVITY AND MILD PAIN IN THE OUTER CORNER OF HER EYE. SHE ALSO REPORTED HER VISION WAS CLOUDY. AT THE ONE WEEK POSTOPERATIVE VISIT, THE PT REPORTED PAIN WHICH SHE DESCRIBED AS MORE OF A PULLING FEELING NEAR THE CANTHUS OF HER EYE WHICH WAS NOT CONSTANT. SHE REPORTED HER LIGHT SENSITIVITY WAS IMPROVING AND THAT SHE WAS SEEING MORE CLEARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH LTD / HUNTINGTON SN6AT5 11006458

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other LISINOPRIL| CARVEDILOL| SIMVASTATIN| DULCOLAX| PRESERVATIVE FREE LIDOCAINE| ASPIR-LOW| AMIODIPINE| BSS| VISCOELASTIC| PRESERVISION