BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 2214266 · Received July 28, 2011

    Report

    Report Number
    1119421-2011-00919
    Event Type
    Other
    Date Received
    July 28, 2011
    Report Date
    June 28, 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
    NL
    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: NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. 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 HAS BEEN REQUESTED. VISSER N, GAST S, GAUER N, NUJITS R (2011) CATARACT SURGERY WITH TORIC INTRAOCULAR LENS IMPLANTATION IN KERATOCONUS: A CASE REPORT. CORNEA 2011; 30(6):720-723. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE REPORTED A KERATOCONUS PATIENT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE ANTICIPATED ASTIGMATISM WAS .46 D AND THE FINAL REFRACTION SIX MONTHS POSTOPERATIVELY WAS DOCUMENTED AS 0.00 -1.50 X 120 DEGREES. THE REFRACTIVE ASTIGMATISM HAD DECREASED FROM -6.00 TO -1.50. THE SURGICALLY INDUCED ASTIGMATISM WAS -1.31 D AT 100 DEGREES. NO COMPLICATIONS OCCURRED, AND THE PATIENT WAS SATISFIED WITH THE POSTOPERATIVE OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60T9 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other