BC04 Laser device complications in facial aesthetics procedures: a MAUDE database study (2015–2025)

Abstract

Facial aesthetic laser procedures are increasingly popular for aesthetic concerns. While generally considered safe, these devices carry a risk of adverse events. Understanding complications associated with facial laser devices can guide clinicians in device selection, patient counselling and risk mitigation. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database provides an accessible compilation of reported device-­related events. Our primary objective was to characterize adverse events from facial aesthetic laser devices reported to MAUDE. Secondary objectives included assessing reporting trends and highlighting safety considerations. We performed a retrospective review of MAUDE reports submitted between 1 August 2015 and 29 August 2025, for devices used in facial aesthetic applications. Reports were screened for device brand, device problem, patient problem, manufacturer and narrative. Descriptive statistics were used to summarize device distribution, frequencies of patient problems, and causes of injury. Burn aetiologies were categorized as device malfunction, user error, operator error or unknown based on narrative review. In total, 224 reports met the inclusion criteria. Device types included diode lasers (106), intense pulsed light or multiapplication systems (58), picosecond lasers (21), alexandrite lasers (20), skin resurfacing lasers (5), radiofrequency microneedling (2), ultrasound-based devices (1) and others. Overall, 271 patient problems were reported. Burns were most frequent (66%), followed by visual impairment (5%), skin discoloration (4%), pain (4%) and scarring (3%). Among 162 burn events with an identified cause, 40% resulted from device malfunction, 28% from user error and 12% from operator error, and 20% were unspecified. Burns represent the majority of complications from facial aesthetic laser devices reported to MAUDE, with nearly 40% attributed to user- or operator-related errors. User errors can be minimized through thorough patient evaluation and counselling. Operator errors underscore the need for strict adherence to established protocols. Combined with consistent maintenance, ­safety-engineered features and ongoing operator education, these measures can reduce preventable injuries and improve outcomes in facial aesthetic procedures.