BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 23847950 · Received December 19, 2025

    Report

    Report Number
    3003288808-2025-00587
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 21, 2025
    Report Date
    March 11, 2026
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    OOE
    PMA / PMN Number
    K141476
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE WAS SUCCESSFULLY VERIFIED PRIOR TO THE DAY OF EVENT. MOST RECENT ONSITE VISIT FROM FIELD SERVICE ENGINEER WAS PERFORMED AND SIGNED SERVICE INSTALLATION RECORD. SYSTEM MEETS SPECIFICATIONS AS PER SERVICE INSTALLATION RECORD. ACCORDING TO THE CLINICAL APPLICATION SPECIALIST, ALL THE PATIENTS FROM PRIOR WEEKS HAVE HAD COMPLETE RESOLUTION OF THEIR DIFFUSE LAMELLAR KERATITIS AND ARE SEEING WELL. NO ON-SITE VISIT BY A FIELD SERVICE ENGINEER WAS IDENTIFIED IN RELATION TO THE REPORTED ISSUE. AS PER LATEST INFORMATION PROVIDED THE MOST LIKELY ROOT CAUSE FOR THE REPORTED DIFFUSE LAMELLAR KERATITIS CASES IS A POORLY MAINTAINED AIR CONDITION SYSTEM THAT LED TO A NON-STERILE AND/OR CONTAMINATED SURGICAL THEATER. NO FURTHER INVESTIGATION OF THE LOGFILES AND REVIEW OF THE TREATMENT REPORTS ARE NECESSARY. THE ROOT CAUSE COULD BE IDENTIFIED AND THE LOGFILES AND TREATMENT REPORTS FROM EARLIER REPORTED CASES FROM THIS CLUSTER WERE REVIEWED AND NO CONTRIBUTING FACTORS FOR DIFFUSE LAMELLAR KERATITIS COULD BE IDENTIFIED. NO PART IS EXPECTED TO BE RETURNED TO DEVICE FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED ISSUE COULD BE DETERMINED AS EXTERNAL (FACILITY ENVIRONMENT RELATED) BASED ON A POORLY MAINTAINED AIR CONDITIONER SYSTEM. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    H.3., H.6.: 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN THE RIGHT EYE AFTER LASIK SURGERY. PATIENT TREATED WITH TOPICAL STEROIDS. ADDITIONAL INFORMATION RECEIVED THAT PATIENT DOING WELL IN POST OPERATIVE REGIMEN. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES FOR PATIENT¿S INITIALS, JS IN THE LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164639 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC LASER OOE WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Other| R