BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VISCOELASTIC

    MDR report key: 2452469 · Received February 10, 2012

    Report

    Report Number
    3002037047-2012-00033
    Event Type
    Injury
    Date Received
    February 10, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 11, 2012
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE RETURNED. NO EVALUATION CAN BE DONE BECAUSE THERE WAS NO COMPLAINT SAMPLE/NO LOT NUMBER PROVIDED BY THE REPORTER. THE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE INITIAL REPORTER ON 01/12/2012 AND 02/07/2012 BY PHONE REGARDING CONTACT INFORMATION FOR THE SURGEON'S COLLEAGUE. THE INITIAL REPORTER HAS BEEN UNABLE TO PROVIDE THE INFORMATION; THEREFORE, NO FOLLOW-UP COULD BE CONDUCTED WITH THE SURGEON'S COLLEAGUE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT HER SURGEON'S COLLEAGUE (IN ANOTHER STATE) HAS AN UNKNOWN NUMBER OF PATIENTS WHO HAVE HAD TASS (TOXIC ANTERIOR SEGMENT SYNDROME) REACTIONS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. THE REPORTED SYMPTOMS INCLUDE EXCESSIVE THAN NORMAL INFLAMMATION AND FIBRIN-COATED IOLS THAT TRACK BACK TO WOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN VISCOELASTIC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INTRAOCULAR LENS (UNSPECIFIED)