BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2130211 · Received June 10, 2011

    Report

    Report Number
    1119421-2011-00732
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 12, 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
    MO, 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 IOL MET RELEASE CRITERIA. THE REPORTER INDICATED THE USE OF AN UNAPPROVED VISCOELASTIC. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 05/16/2011 AND 05/19/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 05/27/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL COORDINATOR REPORTED A PATIENT WHO WAS UNHAPPY WITH HER VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE REPORTED THAT THE PATIENT'S BCVA IS NOT AS GOOD AS INITIALLY AFTER SURGERY. A YAG PROCEDURE WAS PERFORMED BUT THIS DID NOT IMPROVE VISION. THE COORDINATOR REPORTED THAT THE PATIENT HAS BEEN REFERRED TO A RETINAL SPECIALIST. THE PATIENT REPORTED SHE CONTINUES TO WORK WITH HER SURGEON AND WILL SEEK A SECOND OPINION. SHE STATED SHE FUNCTIONS WITHOUT GLASSES BUT HAS TO USE READERS AT TIMES. SHE ALSO REPORTED THAT THE FELLOW EYE IS IMPLANTED WITH THE SAME MODEL LENS AND IS "FINE." IN A FOLLOW-UP, THE SURGEON REPORTED THE EVENT CONTINUES AND THE CAUSE OF THE EVENT IS UNKNOWN. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10932630

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention MONARCH DELIVERY SYSTEM| AMVISC PLUS