BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC UNK

    MDR report key: 2496225 · Received March 14, 2012

    Report

    Report Number
    3002037047-2012-00059
    Event Type
    Injury
    Date Received
    March 14, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 13, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. ADDITIONAL INFORMATION WAS REQUESTED ON 02/14/2012 AND 02/21/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 03/02/2012. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A CASE OF TASS (TOXIC ANTERIOR SEGMENT SYNDROME) ONE DAY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE STATED THAT IT HAD BEEN THE SECOND IOL SURGERY OF THE DAY WHICH WAS UNCOMPLICATED AND LASTED TEN MINUTES. THE PATIENT EXPERIENCED PAIN AT ONE DAY POST OPERATIVELY AND A LAYER OF WHITE BLOOD CELLS IN THE CHAMBER WAS NOTED. THE PATIENT IS BEING TREATED BY A RETINAL SPECIALIST. IN A FOLLOW-UP, THE ADMINISTRATOR REPORTED THE EVENT CONTINUES AND IS EXPECTED TO RESOLVE WITH TREATMENT WHICH IS ONGOING. IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE VISCOELASTIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SN60WF INTRAOCULAR LENS| BROMDAY| LIDOCAINE| OFLOXACINE| BETADINE| VIGAMOX| INFINITI HANDPIECE| MORNACH D CARTRIDGE| IA HANDPIECE| EPINEPHRINE| ALPHAGAN| KELMAN TIP| BSS