BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1914413 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01300
    Event Type
    Other
    Date Received
    November 19, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 22, 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. ADD'L INFO WAS REQUESTED ON 10/28/2010 AND 11/10/2010 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE REC'D ON 10/22/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED EIGHT PTS EXPERIENCING A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE REC'D AND INDICATED THAT AN LRI PROCEDURE WAS PERFORMED AT THE TIME OF THE IOL IMPLANT SURGERY FOR THE RESIDUAL CYLINDER. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE THIRD PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10901922

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other VISCOELASTIC| SIMVASTATIN| FISH OIL| ASPIRIN (DAILY MEDICATION)| PRESERVATIVE FREE LIDOCAINE| LOTREL| METOPROLOL| BSS| MULTIVITAMINS| JANUVIA