DermaV WINDOW HOLDER ASSY_GL19Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08809447655260), received between Aug 7, 2025 and Aug 7, 2025 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ERYTHEMA MORE THAN 2 MONTHS POST ROSACEA TREATMENT ON THE MID FACE AND CHEEKS USING DERMAV. THIS WAS REPORTED TO BE THE PATIENTS FIFTH (5TH) TREATMENT IN TOTAL.

  Patient problems: Erythema

  MAUDE report 22738489 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ERYTHEMA MORE THAN 2 MONTHS POST ROSACEA TREATMENT ON THE MID FACE AND CHEEKS USING DERMAV. THIS WAS REPORTED TO BE THE PATIENTS FIFTH (5TH) TREATMENT IN TOTAL. CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO SITE TO PERFORM DEVICE EVALUATION. DURING VISUAL INSPECTION, CYNOSURE LUTRONIC FSE FOUND A SPOT ON THE ADAPTER LENS FOR THE 15,18,22. THE CUSTOMER WAS INSTRUCTED HOW TO CLEAN THE LENS AND HANDPIECE WINDOW. A SMALL PERMANENT MARK WAS ALSO OBSERVED ON THE LENS IN THE SPOT SIZE ADAPTER. FSE RECOMMENDED THAT THE PROVIDER ORDER NEW LENS FOR THE 15,18,22. IT IS UNKNOWN IF THESE FINDINGS CONTRIBUTED TO THE PATIENTS REPORTED SIDE EFFECTS. CYNOSURE LUTRONIC CLINICAL REACHED OUT TO THE SITE TO COLLECT ADDITIONAL INFORMATION. CYNOSURE LUTRONIC CLINICAL DETERMINED THE EVENT TO BE INCONCLUSIVE. THE TREATMENT PARAMETERS USED FOR THE MOST RECENT TREATMENT WERE REVIEWED AND FOUND TO BE WITHIN RECOMMENDED SETTINGS. CYNOSURE LUTRONIC CLINICAL STATES, "IT IS UNKNOWN IF ERYTHEMA WAS PRESENT BEFORE BEGINNING TREATMENT AND IT IS UNKNOWN HOW THE SKIN REACTED TO TREATMENT WITHOUT AFTER TREATMENT IMAGES." THE PATIENT WAS PRESCRIBED ELTA MD MOISTURE SEA

  Patient problems: Erythema

  MAUDE report 22738119 ↗