BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 2130195 · Received June 10, 2011

    Report

    Report Number
    1119421-2011-00707
    Event Type
    Injury
    Date Received
    June 10, 2011
    Report Date
    May 11, 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
    GA, 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: THE LOT/SERIAL NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE PRODUCT WAS NOT RETURNED AND NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN 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 WAS REQUESTED ON 05/27/2011 AND 06/06/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. GAYTON J, SEABOLT, R. CLINICAL OUTCOMES OF COMPLEX AND UNCOMPLICATED CATARACTOUS EYES AFTER LENS REPLACEMENT WITH THE ACRYSOF TORIC IOL. J REFRACT SURG 2011;27(1):56-62. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE REPORTED TWO PATIENTS IN A RETROSPECTIVE STUDY WITH COMPLICATIONS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. FOR THIS PATIENT IT WAS REPORTED THAT THE PATIENT HAD A SNEEZING SPELL TWO DAYS AFTER SURGERY AND FELT THAT HIS VISION WAS DECREASED FOLLOWING THIS. THE EYE RECEIVED SEVERAL POSTOPERATIVE CORRECTIONS INCLUDING CAPSULOTOMY, LASER EPITHELIAL KERATOMILEUSIS AND LIMBAL RELAXING INCISIONS. THE FINAL UNCORRECTED DISTANCE VISUAL ACUITY WAS 20/25. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60T5 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention