Dermatology: Practical and Conceptual Research Letter | Dermatol Pract Concept. 2024;14(3):e2024174 1 Keep an Eye on At-Home Devices: Energy-Based Acne and Anti-Aging Devices are Associated with Ocular Adverse Events in a Retrospective Analysis Using the MAUDE Database Rachel C. Hill1, Shari R. Lipner2 1 Weill Cornell Medical College, New York, NY, USA 2 Weill Cornell Medicine, Department of Dermatology, New York, NY, USA Key words: acne, photoaging, MAUDE, medical device report, adverse events Citation: Hill RC, Lipner SR. Keep an Eye on At-Home Devices: Energy-Based Acne and Anti-Aging Devices are Associated with Ocular Adverse Events in a Retrospective Analysis Using the MAUDE Database. Dermatol Pract Concept. 2024;14(3):e2024174. DOI: https://doi.org/10.5826/dpc.1403a174 Accepted: March 24, 2024; Published: July 2024 Copyright: ©2024 Hill et al. This is an open-access article distributed under the terms of the Creative Commons Attribution- NonCommercial License (BY-NC-4.0), https://creativecommons.org/licenses/by-nc/4.0/, which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original authors and source are credited. Funding: None. Competing Interests: None. Authorship: Both the authors have contributed significantly to this publication. Corresponding Author: Shari R. Lipner MD, PhD, 1305 York Avenue, NY, NY 10021. Phone: 646-962-3376 Fax: 646-962-0033. Email: shl9032@med.cornell.edu Introduction Non-pharmacologic therapies, including at-home energy- based devices, are popular treatment options for acne and photoaging [1]. In a 2022 survey study of 1,571 outpatient dermatology patients, 74.41% reported treating their acne with non-pharmacologic, complementary and alternative medicine treatments, with 41.86% using them because they are natural, safe, and without side effects [2]. Energy-based devices are available over-the-counter following 510 (k) premarket notification approval by the US Food and Drug Administration (FDA) [3]. Since these devices undergo much less stringent safety and efficacy endpoints than pre- scription medications, but are often sought out by patients and dermatologist recommended, we aimed to character- ize adverse events (AEs) associated with at-home acne and anti- aging energy-based devices [4]. Methods We analyzed medical device reports (MDRs) detailing at- home acne and anti-aging devices submitted to the FDA Manufacturer and User Facility Device Experience (MAUDE) Database, which collects AE reports submitted to the FDA related to medical devices, 2013-2023. Results and Discussion There was a total of 87 at-home acne and anti-aging energy-based devices MDRs, and mean patient age was 41.3 years, with 52% females. Most MDRs related to injuries (N = 75, 86%), with fewer due to device malfunction (N = 12, 14%). Fifty-four MDRs required a medical visit (N = 54, 62%), and 70% (N = 61) of MDRs required 2 Research Letter | Dermatol Pract Concept. 2024;14(3):e2024174 Table 1. Characteristics of Adverse Event Reports Secondary to At-Home Acne and Anti-Aging Devices 2013-2023 Adverse Event Information N (%) # of Events 87 Device Type: Light-based device targeting acne 49 (56%) Transcutaneous electrical stimulator device targeting photoaging 18 (21%) Light-based device targeting photoaging 11 (13%) Radiofrequency coagulation device targeting photoaging 3 (3%) Light-based device targeting both acne and photoaging 3 (3%) Othera 3 (3%) Medical Complicationb Ocular injury 28 (32%) Rashc 23 (26%) Headache/migraine 16 (18%) Dyspigmentation 11 (13%) Burn 8 (9%) Pain 8 (9%) Arrhythmia 6 (7%) Dizziness 5 (6%) Burning/tingling sensation 4 (5%) Light sensitivity 4 (5%) Swelling/edema 4 (5%) Otherd 41 (47%) Outcome: Required medical visit 54 (62%) No medical visit required 3 (3%) Need for medical visit not reported 30 (34%) Management/Treatment:b Non-antibiotic prescription medications 16 (18%) Hospitalization/disability 9 (10%) Over-the-counter treatment 8 (9%) Surgery/invasive procedure 7 (8%) Advanced imaging 6 (7%) Antibiotics 5 (6%) Cardiac/blood pressure monitoring 4 (5%) Laboratory tests 2 (2%) Glasses/eye patch 2 (2%) None 2 (2%) Not listed 47 (54%) aOther includes electrically powered dermabrasion brush, microcurrent facial device, electrically powered muscle stimulator, all (N = 1); bCould be classified into >1 category. cRash includes skin irritation/inflammation/peeling (N = 10, 11%), erythema (N = 7, 8%), rash (N = 2, 2%), dry skin (N = 2, 2%), hypersensitivity/allergic reaction (N = 2, 2%). dOther includes: cyst, electric shock, laceration, scarring, pruritus (all N = 3), dysphagia/odynophagia, seizures, hemorrhage/bleeding (all N = 2), hair loss/hair thinning, miscarriage, physical asymmetry, tooth fracture, dehydration, bradycardia/hypotension, palpitations, irregular heartbeat, muscle/tendon damage, acne, ulcer, loss of consciousness, insomnia, dyspnea, chest pain, anxiety, syncope, nausea, gum and teeth sensitivity, fatigue (all N = 1). Research Letter | Dermatol Pract Concept. 2024;14(3):e2024174 3 management. Ocular injury (N = 28, 32%), rash (N = 23, 26%), headache/migraine (N = 16, 18%), and dyspigmenta- tion (N = 11, 13%) were the most common AEs. Four ocular injury cases (14%) required hospitalization, 3 eye surgery (11%), and 3 an antibiotic (11%). We found that ocular injury, rash, headache/migraine, and dyspigmentation were the most common AEs associ- ated with at-home energy-based devices targeting acne and photoaging, with most patients requiring medical attention. While 22/28 MDRs reported ocular injuries that were asso- ciated with a device recalled in 07/2019, 16/22 followed the recall date, and 6/28 were associated with devices that are still on the market. While the total number of patients using these devices is unknown, AEs associated with these devices were previously thought to be relatively uncommon. In a systematic review on safety and efficacy of home-use dermatologic devices including 3 randomized controlled trials specific to light emitting acne devices (N = 12), AEs were reported in only 3 patients (2.3%), including xerosis (N = 2) and erythema with desquamation (n=1) [4]. Similarly, in an unblinded, non-con- trolled trial of 22 patients using an LED device to treat pho- toaging, no AEs were reported during or after therapy [5]. Limitations include sample size, missing information in MDRs, and unknown number of total patients using these devices. Conclusion In summary, the most common AEs reported in patients us- ing at-home acne and anti-aging energy-based devices were ocular injury, rash, headache/migraine, and dyspigmentation. As consumer demand for at-home devices increases with in- terest in alternative medicine, awareness of such AEs among dermatologists is critical to educate patients who may opt to purchase them. Patients may be counseled on ocular AE risk with such devices, particularly those with pre-existing eye disease or who take medications associated with ocular photosensitivity. Dermatologists are important advocates for patient safety and can encourage patients to report AEs asso- ciated with the use of such devices to the FDA. References 1. Juhász ML, Levin MK, Marmur ES. A review of available laser and intense light source home devices: A dermatologist’s perspec- tive.  J Cosmet Dermatol. 2017;16(4):438-443. DOI:10.1111 /jocd.12371. PMID: 28741866. 2. Kayıran MA, Karadağ AS, Alyamaç G, et al. Use of Complemen- tary and Alternative Medicine among Patients with Acne Vul- garis and Factors Perceived to Trigger the Disease: A Multicentre Cross-Sectional Study with 1571 Patients.  Indian J Dermatol. 2022;67(3):311. DOI:10.4103/ijd.ijd_745_21. PMID: 36386117. 3. Hession MT, Markova A, Graber EM. 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