BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPOINT 27 GAUGE CAPSULE POLISHER

    MDR report key: 445850 · Received February 26, 2003

    Report

    Report Number
    1643219-2003-00001
    Event Type
    Other
    Date Received
    February 26, 2003
    Date of Event
    January 30, 2003
    Report Date
    February 26, 2003
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Product Code
    HMX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 01/03 WHILE PERFORMING A LEFT CATARACT EXTRACTION, DR. INJECTED VISCO-ELASTIC THROUGH SURGICAL SPECIALTIES CORPORATION'S PRODUCT IN FINISHED GOODS. AFTER INJECTION OF THE VISCO-ELASTIC, REFRACTIVE PARTICLES APPEARED IN THE PATIENT'S LEFT EYE. SOME OF THE PARTICLES WERE IRRIGATED FROM THE PATIENT'S EYE. NUMEROUS PARTICLES REMAINED IN THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPOINT 27 GAUGE CAPSULE POLISHER 27 GAUGE CAPSULE POLISHER HMX SURGICAL SPECIALTIES CORP. 3107 M133680

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention CURRENT MEDICATION IS LUMIGAN 0.03% EYE DROPS. 1| FOREIGN BODIES. PT STATUS AS OF 2/03 IS STABLE.| DROP AT BEDTIME IN BOTH EYES.| REMOVED MINIMAL AMOUNT OF RETAINED INTRAOCULAR| CORRECTIVE SURGERY PERFORMED 2/19/03. DOCTOR ABLE