BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2023734 · Received February 18, 2011

    Report

    Report Number
    1119421-2011-00167
    Event Type
    Other
    Date Received
    February 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 19, 2011
    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
    CA, 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. ADDITIONAL INFORMATION WAS REQUESTED 01/21/2011, 02/08/2011 AND 02/15/2011 BY FAX, PHONE AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/15/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT HAS A HISTORY OF PHOTOREFRACTIVE KERATECTOMY (PRK) FOR HIGH MYOPIA AND CORNEAL SCARRING. THE PATIENT HAS ALSO DEVELOPED CHRONIC CYSTOID MACULAR EDEMA (CME). IN A FOLLOW-UP, THE SURGEON REPORTS THE EVENT CONTINUES. IN HIS OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. THE SURGEON REPORTS THE IOL NEEDS TO BE EXCHANGED AND THAT THE EVENT WILL RESOLVE FOLLOWING THE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 10960107

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other DUOVISC