BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 2551749 · Received April 13, 2012

    Report

    Report Number
    3003288808-2012-00148
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 15, 2012
    Manufacturer
    WAVELIGHT AG
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CANCELED SERVICE REQUEST. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4). ADDITIONAL INFO FROM THE USER FACILITY REPORT: D.4.: MODEL #ALLEGRETTO; SERIAL # (B)(4).

    Description of Event or Problem · 1

    RECEIVED A VOLUNTARY MEDWATCH FROM THE FACILITY REPORTING A PT WITH A PERIPHERAL ULCER IN THE RIGHT EYE 5 DAYS FOLLOWING UNEVENTFUL PRK SURGERY. CULTURE WAS NEGATIVE FOR GROWTH. THE PT WAS TREATED WITH ANTIBIOTICS AND NON-STEROIDAL ANTI INFLAMMATORY DRUGS. THE SITE VERIFIED THE AUTOCLAVE SPORE TEST PASSED THAT WEEK, INDICATOR STRIPS PASSED, NO COMMON LOT NUMBER OR BRANDS OF BANDAGE CONTACT LENSES WERE USED AND THE SAME VIAL OF MMC (MITOMYCIN C) WAS USED ON ALL PATIENTS TREATED THE SAME DAY. AT FOUR WEEKS POST-OP UCVA AND BCVA WERE 20/25 IN THE RIGHT EYE. ADDITIONAL INFO FROM THE USER FACILITY REPORT: PT UNDERWENT UNEVENTFUL PRK W MMC (B)(6) 2012, PRK WITH MMC 0.02% FOR 12 SECONDS OU. PRESENTED AT 5 DAY POST UP WITH PERIPHERAL ULCER OD AT POD 6 - NO EPI DEFECT - CULTURE NEGATIVE FOR GROWTH - PT 1 OF 4 PTS WITH INFILTRATE 1 EYE IN EARLY POST OP PERIOD. EIGHT PTS 16 EYES TREATED THAT DAY. REFERRED SURGEON TO OUR MEDICAL ADVISOR FOR SUPPORT. SURGEON DOES NOT START STEROIDS UNTIL EIP HEALED. ADVISOR THOUGH INFILTRATES NSAID INFILTRATES. AUTOCLAVE SPORE TEST PASSED THAT WEEK. INDICATOR STRIPS PASSED, NO COMMON LOT NUMBERS OR BRANDS TO BCLS. SAME MMC VIAL USED ON ALL PTS THAT DAY. PT TREATED ON TRANSPORTABLE ALLEGRETTO. WE DID NOT RECEIVED INCIDENT REPORTS UNTIL (B)(6) 2012. PT LAST SEEN (B)(6) 2012, VASC 20/25 OP, 02/25 OS, RXM -0.25 + 0.25 X 040 20/25+ OD, PLANO + 0.25 X 115 20/20 - OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT AG 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R