BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2551751 · Received April 13, 2012

    Report

    Report Number
    3003288808-2012-00150
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 15, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/PO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CANCELLED SERVICE REQUEST A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(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 CORNEAL ULCER, CONSISTENT WITH PSEUDOMONAS, IN THE LEFT EYE 5 DAYS FOLLOWING UNEVENTFUL PRK SURGERY. CULTURES WERE NEGATIVE. 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 PTS TREATED THE SAME DAY. AT TWO WEEKS POST-OP UCVA WAS 20/60 IN THE LEFT EYE. ADDITIONAL INFO FROM THE USER FACILITY REPORT: PT UNDERWENT UNEVENTFUL PRK WITH MMC (B)(6) 2012 PRK WITH MMC 0.02% FOR 12 SECONDS OU. PRESENTED AT 5 DAY POST OP WITH PERIPHERAL CORNEAL ULCER - CONSISTENT WITH PSEUDOMONAS - CULTURES NEGATIVE - PT 1 OF 4 PTS WITH INFILTRATE/ULCER 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 EPI HEALED. ADVISOR THOUGHT INFILTRATES NSAIO 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 REFERRED TO OPHTHALMOLOGIST IN HIS TOWN FOR CONTINUED CARE. LAST FOLLOW-UP REPORT WE HAVE IS FROM (B)(6) 2012. VASC OS 20/60-2. IMPRESSION - CORNEAL ULCER OS. APPEARS STERILE. POST PRK OU. RECOMMENDATIONS: D/C FORTIFIED GTTS. CILOXAN UNG QID, REFRESH PM QID. D/C DUREZOL. USE FML OID. FOLLOW-UP IN 1 WEEK. WE DON'T HAVE ANY ADDITIONAL FOLLOWUP AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other| R