BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2032417 · Received March 25, 2011

    Report

    Report Number
    1119421-2011-00341
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 03/22/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED IN A FOLLOW UP PHONE CALL ON 03/23/2011. MEDICAL RECORDS WERE RECEIVED ON 03/02/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. AT THE ONE WEEK POSTOPERATIVE VISIT, THE PATIENT REPORTED BLURRED VISION, DIPLOPIA AND SEEING A "BIFOCAL LIKE LINE" SINCE THE IOL IMPLANT. THE PATIENT REPORTED HE WAS NOT COMFORTABLE SEEING THE LINE AND THAT HIS VISION WAS MORE CLEAR IF HE TILTED HIS HEAD BACK. ON EXAMINATION, THE IOL WAS NOTED TO BE ROTATED. THE PATIENT HAS A HISTORY OF HYPERTENSION, CARDIAC BYPASS SURGERY, ANGIOPLASTY, MELANOMA, VILLUS TUMOR, BLEPHARITIS, LID LAXITY, DERMATOCHALASIS, POSTERIOR VITREAL DETACHMENT AND SUSPECTED GLAUCOMA (PRE-EXISTING). THE SURGEON FELT THE VISUAL DISTORTION MIGHT BE DUE TO THE LENS BEING OFF AXIS AND THE UNEXPECTED REFRACTION WAS DUE TO A BIOMETRY ERROR IN THE SPHERICAL EQUIVALENT. IN A FOLLOW UP PHONE CALL WITH THE SURGEON'S SURGERY COORDINATOR, IT WAS REPORTED THE SURGEON PERFORMED A LENS ROTATION IN A SECONDARY SURGICAL PROCEDURE. THE SURGEON AND THE PATIENT WERE PLEASED WITH THE POSTOPERATIVE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 11056502

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention D3| PRED FORTE| SAW PALMETTO| NIACIN| VITAMIN B12| LINSINOPRIL| FISH OIL| INDAPAMIDE| ACUVAIL| ECTROPIN