BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1905602 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01311
    Event Type
    Injury
    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. ADDITIONAL INFORMATION WAS REQUESTED ON 10/28/2010 AND 11/10/2010 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE RECEIVED ON 10/22/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (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 RECEIVED WHICH INDICATED THE FOLLOWING: THIS PT WAS IMPLANTED BILATERALLY. DURING THE IMPLANT SURGERY FOR THIS EYE, IT WAS NOTED THAT THE PUPIL CAME DOWN. AT THE ONE DAY POSTOPERATIVE VISIT, THERE WAS INCREASED INTRAOCULAR PRESSURE FOR WHICH MEDICATION WAS STARTED. THE IOP WAS REPORTED TO BE DECREASED APPROXIMATELY ONE MONTH FOLLOWING THE IMPLANT SURGERY. AT THE ONE WEEK POSTOPERATIVE VISIT, THE PT REPORTED THAT SHE WAS "STILL FEELING LOPSIDED". ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SEVENTH PT, RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 10989300

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention OMEGA DRY EYE| METFORMIN| LISINOPRIL| WELLBUTRIN| CALCIM PLUS MAGNESIUM AND ZINC| GLIPIZIDE| ACTOPLUS| LEOXICAM| B-50 COMPLEX(DAILY MEDICATIONS)| ARTIFICIAL TEARS