BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOOK IRRIGATING ANTERIOR CHAMBER CANNULA 30G

    MDR report key: 278605 · Received May 17, 2000

    Report

    Report Number
    1643219-2000-00001
    Event Type
    Injury
    Date Received
    May 17, 2000
    Date of Event
    August 13, 1999
    Report Date
    May 17, 2000
    Manufacturer
    SURGICAL SPECIALTIES CORP
    Product Code
    HMX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON'S INITIAL REPORT STATED THE CANNULA BLEW OFF THE TIP OF SYRINGE AND CREATED A LARGE IRIDODIALYSIS, ZONULAR RUPTURE WITH IMMEDIATE COPIOUS HEMORRHAGING, VITRECTOMY PERFORMED TO ATTEMPT TO REPAIR IRIS. IRIS WAS TOO BROKEN UP TO SUTURE. INTRAOCULAR LENS RETRIEVED WITH FORCEPS. IN SURGEON'S LETTER TO RETINAL SPECIALIST, SURGEON STATED CANNULA SEPARATED FROM SYRINGE AND EITHER THE CANNULA OR A STRONG STREAM OF BSS (BALANED STERILE SALINE) ENTERED THE EYE, FORMED AN IRIDODIALYSIS TEMPORALLY, LACERATED THE IRIS, DISPLACED THE IOL (INTRAOCULAR LENS) AND TORE ZONULES AND THE CAPSULE. VERBAL COMMUNICATION FROM THE INITIAL REPORTER STATED THAT ADDITIONAL SURGERY WAS PERFORMED ON 10/12/1999. THE POST-OPERATIVE EVAL ON 11/8/1999 REVEALED THAT THE PT HAD NO SIGHT IN THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOK IRRIGATING ANTERIOR CHAMBER CANNULA 30G IRRIGATING ANTERIOR CHAMBER CANNULA 30G HMX SURGICAL SPECIALTIES CORP 3405 MJ61420

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Disability