enlighten enlighten IIIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816722021649), received between May 23, 2025 and May 23, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  CUTERA, INC., RECEIVED A REPORT FROM A CLINIC INDICATING THAT A LASER TECHNICIAN SUSTAINED AN OCULAR INJURY ("PUPIL BURN") DURING A TATTOO REMOVAL PROCEDURE INVOLVING THE ENLIGHTEN III LASER SYSTEM AND AN UNSPECIFIED "PATCH." ACCORDING TO THE CLINIC, THE TECHNICIAN WAS STRUCK IN THE EYE BY A LASER BEAM "THAT REFLECTED OFF THE PATCH" AND WAS NOT WEARING PROTECTIVE EYEWEAR AT THE TIME OF THE INCIDENT. FOLLOWING THE INJURY, THE TECHNICIAN WAS REFERRED TO A SPECIALIST AND DIAGNOSED WITH A BURN TO THE PUPIL. BASED ON THE INFORMATION PROVIDED, THE INCIDENT APPEARS TO INVOLVE OPERATOR ERROR, SPECIFICALLY THE FAILURE TO USE APPROPRIATE EYE PROTECTION AS REQUIRED BY THE ENLIGHTEN III INSTRUCTIONS FOR USE (IFU). THE CLINIC REPORTED THAT THE LASER BEAM REFLECTED OFF THE "PATCH" USED DURING THE PROCEDURE; HOWEVER, NO ADDITIONAL INFORMATION REGARDING THE BRAND OR SPECIFICATIONS OF THE PATCH WAS PROVIDED. THE ENLIGHTEN III IFU INCLUDES EXPLICIT WARNINGS REGARDING THE CRITICAL IMPORTANCE OF PROTECTIVE EYEWEAR FOR ALL INDIVIDUALS PRESENT DURING LASER OPERATION. HOWEVER, THE IFU DOES NOT ADDRESS THE USE OF THIRD-PARTY PATCHES IN CONJUNCTION WITH THE ENLIGHTEN III LASER SYSTEM. THERE HAS BEEN NO IND

  Patient problems: Burn(s); Eye Injury

  MAUDE report 22081619 ↗