Icon 105-2500-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841494100018), received between Feb 22, 2019 and Jun 2, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Output Problem

  IT WAS REPORTED THAT THE ICON FOOT PEDAL CONTINUED TO FIRE EVEN WITHOUT OPERATOR PRESSING IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364937 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CYNOSURE LEGAL RECEIVED DOCUMENTS DISCLOSING A LAWSUIT ON (B)(6) 2025 REGARDING AN EVENT WHERE A PATIENT WAS BURNED FOLLOWING AN ICON TREATMENT THAT WAS PERFORMED ON (B)(6) 2021. WITHIN THE DOCUMENTS RECEIVED, PERMANENT SCARRING FROM BURNS WERE MENTIONED. CYNOSURE TEAM REVIEWED ITS COMPLAINT DATABASE AND NO RECORDS OF THIS EVENT HAD BEEN PREVIOUSLY REPORTED.

  Patient problems: Burn(s)

  MAUDE report 21437804 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED PERMANENT INJURY OF A SCAR FOLLOWING A TREATMENT USING ICON MAX G HANDPIECE.

  Patient problems: Scar Tissue; Skin Discoloration

  MAUDE report 16768229 ↗
• InjuryNov 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT EXPERIENCED DISFIGUREMENT AND SKIN WOUNDS AFTER A TREATMENT WAS PERFORMED WITH ICON MAX G HANDPIECE. SITE HAS NOT SEEN OR BEEN IN CONTACT WITH THE PATIENT SINCE THE LAST TREATMENT ON (B)(6) 2020 AND HAVE RECEIVED LITIGATION PAPERS.

  Patient problems: Insufficient Information

  MAUDE report 12860082 ↗
• MalfunctionMar 5, 2021Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT ICON RELEASED 4 EXTRA PULSES OF RADIATION AFTER THE USER RELEASED THEIR FOOT OFF THE FOOT PEDAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423870 ↗
• InjuryFeb 22, 2019Use of Device Problem; Use of Device Problem

  PATIENT HAD MEDICAL INTERVENTION FOLLOWING A HAIR REMOVAL PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8362901 ↗