BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VBEAM PRIMA LASER SYSTEM

    MDR report key: 22779638 · Received August 11, 2025

    Report

    Report Number
    3016496662-2025-00006
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    July 7, 2025
    Report Date
    August 26, 2025
    Manufacturer
    CANDELA CORPORATION
    Product Code
    GEX
    UDI-DI
    0817495022963
    PMA / PMN Number
    K230990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL EVENT IS REPORTED WITH TWO INDIVIDUALS - THE DOCTOR AND ASSISTANT - SUSTAINING ISSUES WITH EYESIGHT FOLLOWING WEARING LASER SAFETY GOGGLES, WHICH ARE SAID TO HAVE BEEN THE INCORRECT ONES DELIVERED, AND THEN SUBSEQUENTLY USED. THE VBEAM PRIMA USER MANUAL CAUTIONS THE FOLLOWING UNDER OPTICAL PRECAUTIONS - LASER EYE HAZARDS AND SAFETY EYEWEAR: USE ONLY SAFETY EYEWEAR WITH AN OPTICAL DENSITY OF GREATER THAN OR EQUAL TO 5.0 BETWEEN 592 AND 596 NANOMETERS (NM). THE LASER BEAM EMITTED BY THE VBEAM PRIMA LASER SYSTEM CAN CAUSE LOSS OF VISION. THE LASER OPERATES AT THESE WAVELENGTHS: · 595 NM, WITHIN THE VISIBLE SPECTRUM · 1064 NM, OUTSIDE THE VISIBLE SPECTRUM. THE CORNEA AND LENS OF THE EYE ARE TRANSPARENT TO VISIBLE LIGHT. ANY ENERGY EMITTED BY THE VBEAM PRIMA LASER SYSTEM THAT ENTERS THE EYE WILL BE FOCUSED DIRECTLY ON THE RETINA. DIRECT CONTACT OF THE LASER BEAM ON THE RETINA CAN CAUSE TEMPORARILY CLOUDED VISION, RETINAL LESIONS, LONG-TERM SCOTOMA (VISION ABSENCE IN AN ISOLATED AREA), LONG TERM PHOTOPHOBIA (SENSITIVITY TO LIGHT) AND/OR LOSS OF VISION. AND UNDER OPTICAL SAFETY PRECAUTIONS: FOLLOW THESE PRECAUTIONS TO ENSURE OPTICAL SAFETY: · ENSURE THAT ALL PERSONNEL WEAR APPROPRIATE SAFETY EYEWEAR WHENEVER THE LASER SYSTEM IS ON. · NEVER LOOK DIRECTLY INTO THE LASER BEAM EVEN WHEN WEARING PROTECTIVE EYEWEAR. COMPLAINT DOES NOT ALLEGE A TECHNICAL ISSUE WITH LASER. DACH SERVICE MANAGER FOLLOWED UP WITH CUSTOMER TO REQUEST CURRENT USE/STATUS OF LASER. PER CUSTOMER RESPONSE, "THE V-BEAM LASER HAS BEEN WORKING PROPERLY SINCE THE INCIDENT WITH THE LASER SAFETY GOGGLES." PATIENT IMPACT INFORMATION WAS ALSO REVIEWED. THERE IS NOTHING TO INDICATE THAT THE DEVICE PARAMETERS WERE NOT USED IN ACCORDANCE WITH TREATMENT GUIDELINES. ALTHOUGH THE CUSTOMER RECEIVED INCORRECT SAFETY EYEWEAR, THE USER MANUAL CAUTIONS THAT THE USER ENSURE THAT ALL PERSONNEL WEAR APPROPRIATE SAFETY EYEWEAR WHENEVER THE LASER SYSTEM IS ON. THEREFORE, THE MOST PROBABLE CAUSE IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT, INDICATING THE INTERACTION BETWEEN THE USER AND DEVICE, OR SAMPLE, CAUSED OR CONTRIBUTED TO THE ERROR. THIS INCLUDES UNINTENDED INAPPROPRIATE USE OF THE DEVICE AND INCORRECT SAMPLE PREPARATION. REVIEW OF RISK MANAGEMENT DOCUMENTS DEMONSTRATE THAT THE REPORTED RISK IS CAPTURED AND ASSESSED. NO FURTHER CORRECTIVE ACTIONS REQUIRED FOR THIS COMPLAINT AT THIS TIME. RISK INFORMATION IS THEN SUBJECT TO PERIODIC RISK REVIEWS AND TREND TRACKING, WHICH MAY REQUIRE ADDITIONAL ACTIONS AND/OR REVIEW.

    Description of Event or Problem · 0

    A CUSTOMER IN GERMANY REPORTED THAT THE "WRONG LASER SAFETY GOGGLES WERE DELIVERED" WHICH "LED TO SIGNIFICANT COMPLICATIONS" FOR TWO PROVIDERS. BOTH "DOCTOR AND MFA (ASSISTANT) HAD TO ATTEND AN OPHTHALMOLOGIST'S APPOINTMENT DUE TO EYE PROBLEMS." CUSTOMER REPORTED DOCTOR AND ASSISTANT WORE THE WRONG SAFETY EYEWEAR WHILE USING THE VBEAM PRIMA; ONE (1) PULSE, 1.5 MILLISECONDS, 7.5 JOULES. WORK STOPPED AND AN OPHTHALMOLOGIST WAS IMMEDIATELY CONSULTED. CUSTOMER REPORTS TEMPORARY VISUAL IMPAIRMENT, WITHOUT PATHOLOGICAL FINDINGS, AND NOTES LONG-TERM CONSEQUENCES ARE NOT FORESEEABLE. THERE WAS NO IMPACT NOR INJURY TO A PATIENT. ADDITIONAL INFORMATION SOLICITED. THIS REPORT CAPTURES IMPACT TO THE MFA (ASSISTANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271045 VBEAM PRIMA LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX CANDELA CORPORATION 9914-00-9080 0817495022963

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other