BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2214086 · Received July 21, 2011

    Report

    Report Number
    1119421-2011-00901
    Event Type
    Other
    Date Received
    July 21, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 21, 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
    NC, 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. PHOTOS WERE RECEIVED AND REVIEWED BY A COMPANY REPRESENTATIVE WHO DETERMINED THAT PROLIFERATIVE CELLULAR GROWTH IS PRESENT. ROOT CAUSE: NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. 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. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(4) 2011 BY PHONE, FAX, AND MAIL. PHOTOS WERE RECEIVED ON (B)(4) 2011. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, FOR SOME OF HER PATIENTS, SHE HAS OBSERVED "CREEPING CRUD" COMING FROM THE UNDERSIDE OF THE ANTERIOR CAPSULE. SHE REPORTED THAT SHE HAS BEEN IMPLANTING THIS MODEL IOL FOR TWO TO THREE YEARS AND HAS OBSERVED THIS ISSUE FOR THE PAST YEAR. THE SURGEON PROVIDED DATE OF SURGERIES FOR TWO OF THE PATIENT ((B)(6) 2010 AND (B)(6) 2011). IN A FOLLOW-UP, THE SURGEON REPORTED THAT, WITH THIS LENS MODEL, SHE SUSPECTS APPROXIMATELY 50 PERCENT OF PATIENTS HAVE ANTERIOR CAPSULE "ON-GROWTH", WITH FOUR PATIENTS PRESENTING "RATHER AGGRESSIVELY." SHE REPORTED THAT NO VISUAL ACUITY HAS BEEN AFFECTED ON ANY OF THE PATIENTS; HOWEVER, THE "ON GROWTH" IS STARTING TO APPROACH THE VISUAL AXIS OF THE FOUR PATIENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE UNKNOWN PATIENTS (NO IDENTIFIERS PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other