BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT

    MDR report key: 2052545 · Received April 8, 2011

    Report

    Report Number
    3002037047-2011-00017
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. NO ROOT CAUSE COULD BE IDENTIFIED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON ON 03/09/2011 AND 03/22/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED DURING NUCLEAR CATARACT EXTRACTION THE ANTERIOR CHAMBER WAS FILLED WITH THE VISCOELASTIC AND IMMEDIATELY AFTER THE FOOTSWITCH WAS PRESSED A THERMAL CORNEAL BURN WAS OBSERVED. HE STATED THREE SUTURES WERE USED AND THE PATIENT WAS HOSPITALIZED. THE SURGEON NOTED POSTOPERATIVE THE PATIENT HAS INDUCED ASTIGMATISM. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO STATED THE EVENT OCCURRED ON (B)(6) 2011 AND DURING SURGERY 3 SUTURES WERE PLACED AND AIR INSTILLATION INTO THE ANTERIOR CHAMBER WAS COMPLETED. HE REPORTED ON (B)(6) 2011 THE PATIENT WAS PRESCRIBED A CORTICOSTEROID FIVE TIMES A DAY. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED AND 1 SUTURE WAS REMOVED. HE NOTED ON (B)(6) 2011 A SECOND SUTURE WAS REMOVED. ON (B)(6)2011, A SECONDARY PROCEDURE WAS PERFORMED FOR CORNEAL RE-SUTURE AND AIR INSTILLATION INTO THE ANTERIOR CHAMBER. HE NOTED THE PROCEDURE TOOK 27 MINUTES. THE SURGEON REPORTED THE PATIENT WAS DISCHARGED ON (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R OZIL HANDPIECE| OZIL 12 REVERSE TIP| OPEGUARD NEO OXIGLUTATIONE| INFINITI VISION SYSTEM