BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVISC (IN DUOVISC)

    MDR report key: 2070135 · Received April 22, 2011

    Report

    Report Number
    3002037047-2011-00019
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE, THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED VIA PHONE ON 03/28/2011, 03/29/2011 AND 04/13/2011; VIA E-MAIL ON 03/28/2011; VIA MAIL ON 04/28/2011. AT THIS TIME ADDITIONAL INFO HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPORTED, A GRAY FOREIGN MATERIAL WAS FOUND IN THE PT'S EYE FOLLOWING THE INJECTION OF THIS PRODUCT. THE REPORTER NOTED, THE DOCTOR IRRIGATED AND REMOVED THE MATERIAL. SHE STATED ONCE THE MATERIAL WAS REMOVED, THE PT RECEIVED COPIOUS IRRIGATION AND WAS TREATED WITH INTRAOCULAR ANTIBIOTICS. SHE STATED FOLLOWING SURGERY, THE PT WAS PLACED ON ORAL ANTIBIOTICS FOR A FEW DAYS. THE REPORTER NOTED, THE PT IS CONTINUING TO BE MONITORED AT THIS TIME. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention