BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2093677 · Received April 20, 2011

    Report

    Report Number
    1119421-2011-00439
    Event Type
    Other
    Date Received
    April 20, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    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. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: NO SERIAL/LOT NUMBER OR SAMPLE WAS PROVIDED BY THE CUSTOMER. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. INFORMATION PROVIDED INDICATES THE DOCTOR IS NOT BLAMING THE LENS. BOTH THE SURGEON AND PATIENT ARE SATISFIED. ACTION TAKEN: FURTHER ACTION IS NOT 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 ON 03/22/2011 AND 04/06/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON HAD PERFORMED LIMBAL RELAXING INCISIONS AT THE TIME OF THE IOL IMPLANT FOR ASTIGMATISM CORRECTION. THE SURGEON STATED HE HAD AIMED FOR PLANO AS AN OUTCOME, BUT THE PATIENT'S POSTOPERATIVE UCVA WAS 20/30. THE SURGEON DOES BLAME THE IOL FOR THE OUTCOME OF THE EVENT. BOTH HE AND THE PATIENT ARE SATISFIED WITH THE OPERATIVE OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other