BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    MDR report key: 7682999 · Received July 12, 2018

    Report

    Report Number
    3003288808-2018-01282
    Event Type
    Injury
    Date Received
    July 12, 2018
    Date of Event
    June 26, 2018
    Report Date
    October 17, 2018
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. NO UDI REQUIRED DUE TO THIS DEVICE BEING OUT OF PRODUCTION PRIOR TO THE SEPTEMBER 24, 2014 UDI REGULATION DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: LASER WAS SUCCESSFULLY VERIFIED PRIOR TO AND AFTER THE DAY OF THE TREATMENT. LOGFILE REVIEW FOR THE DATE OF TREATMENT SHOWS NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO REPORTED EVENT. THE TREATMENTS WERE COMPLETED TO 100% AND ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS DURING TREATMENTS AT THIS DAY. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PATIENT THAT HAD A SMALL IATROGENIC ABRASION DURING TREATMENT. A BANDAGE CONTACT LENS WAS PLACED AND ONE THE ONE DAY POST OPERATIVE VISIT THE ABRASION WAS HEALED. THE PATIENT HAD LOOSE EPITHELIUM CAUSING SOME VISUAL DISTORTION AND BLUR. THE PATIENT WAS EXTREMELY WORRIED ABOUT GETTING A PROPER DIAGNOSIS AND CALLED THE FACILITY MULTIPLE TIMES WITH QUESTIONS AND STATING THEY ARE GETTING ANXIETY. THE SITE STATED THE PATIENT WILL BE FINE AND IS CURRENTLY ON TOPICAL STEROID DROPS, LIFTITEGRAST OPHTHALMIC SOLUTION, ARTIFICIAL TEARS AND SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC MEDICATION. THE PATIENT WILL CONTINUE TO BE MONITORED BECAUSE OF THEIR ANXIETY ISSUES OVER THEIR SYMPTOMS. UPON FOLLOW UP, THE SITE STATED THE ABRASION WAS NOT RELATED TO THE EXCIMER TREATMENT. THE PATIENT WAS DOING WELL AT THE LAST FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525272 ALLEGRETTO WAVE EYE-Q EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention