BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACRYSOF RESTOR

    MDR report key: 2231165 · Received August 26, 2011

    Report

    Report Number
    1119421-2011-01057
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 28, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE 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 ROOT CAUSE CANNOT BE DETERMINED. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. NO FURTHER ACTION IS WARRANTED AT THIS TIME. 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 07/29/2011, 08/01/2011, 08/02/2011, 08/04/2011 AND 08/23/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PT WAS DIAGNOSED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) ON THE FIRST POST OPERATIVE DAY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON STATED THERE WAS NO SIGN OF INFECTION AND THE PT WAS REPORTED TO BE IMPROVING WITH THE USE OF STEROIDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS FOR THE THIRD MEDICAL DEVICE ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention PROVISC| CUSTOM PAK-DATE UNK| VISCOAT