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PURPOSE: Personal care and cosmetic products can cause periocular and ocular adverse effects (AEs), for example, ocular surface disease, trauma, and hypersensitivity. The publicly available Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) database includes AE reports by consumers, healthcare practitioners, and manufacturers. The purpose of this study was to characterize ophthalmic AE associated with cosmetics and personal care products reported by the FDA CAERS database. METHODS: AE related to the eye or ocular adnexa from cosmetics submitted by consumers, healthcare practitioners, and manufacturers from January 2004 to June 2022 were identified after filtering using the Medical Dictionary for Regulatory Activities coding system. Demographic information, case outcome, and categories of product and AE were included. Chi-square analysis, with statistical significance at a = 0.05, was performed to ascertain variation in ocular, periocular, and general outcomes by product category. RESULTS: Reports of ophthalmic AEs related to cosmetics per year increased from 2006 to 2018, reaching a maximum of 161 reports in 2018, then decreased from 2018 to 2021. In total, 959 and 1382 unique periocular and ocular AEs were reported. There were 1711 total incidences of reported periocular AEs and 2485 ocular AEs. The most reported periocular AEs were inflammation (770/1711) and hypersensitivity (331/1711). The most reported ocular effects were discomfort (946/2485) and inflammation (709/2485). Ocular, periocular, and general outcomes significantly varied by product category. CONCLUSIONS: Consumers, healthcare practitioners, and manufacturers should be made aware of potential ophthalmic AE and outcomes associated with cosmetics and personal care products.
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Purpose: This report describes the clinical and histological characteristics and management of a keratinized lesion of the palpebral conjunctiva in a 59-year-old male. The lesion was identified as a rare acantholytic variant of squamous cell carcinoma that atypically arose from a non-sun exposed region of palpebral conjunctiva. Management was complete excision via Mohs surgery. Observations: A 59-year-old male presented with ocular irritation and chronic foreign body sensation in the right eye. Exam revealed a keratinized lesion in the right lower tarsal conjunctiva, and an initial shave biopsy was non-diagnostic. 12 months later, the patient presented with similar symptoms and a larger, more irregular lesion for which histopathology of a tarsal-involving excisional biopsy was consistent with acantholytic squamous cell carcinoma with involved margins. The patient subsequently underwent complete excision via Mohs surgery and a secondary reconstruction. Conclusions and importance: Acantholytic variants of squamous cell carcinoma are rare and are described as arising from areas with routine sun exposure. This case reports such a lesion arising from non-sun exposed tarsal conjunctiva, as identified by histopathology of a full-thickness excisional biopsy. The lesion was successfully managed with complete excision via Mohs surgery and secondary reconstruction. Given that this histologic variant may be more aggressive and have higher rates of recurrence than other forms of squamous cell carcinoma, this case highlights the importance of complete excisional biopsy and accurate histopathology of concerning periocular lesions and offers a template for management of similar lesions. The unique presenting location should bring awareness to consideration of this type of malignancy developing on palpebral conjunctiva.
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PURPOSE: To investigate the ocular safety profile of topical perchlorate as a potential preventive treatment for nasolacrimal obstruction associated with excessive use of radioactive iodine therapy. METHODS: Nine Wistar male rats (18 eyes) were randomly assigned to receive an ocular application (topical eye drop on the OD, 3 times a day for 5 days) consisting of either: 1) sterile saline solution, 2) 30 mg/ml NaClO4 or 3) 30 mg/ml KClO4. The rat eyes were examined daily for corneal cloudiness/clarity, discharge, mucous secretions, conjunctival injection, eyelid erythema, and/or changes in behavior. Seven days after the first dose, the rats were euthanized and OU were harvested, fixed, embedded in paraffin, and stained with H&E and Masson's trichrome using standard techniques. RESULTS: The data collected over the 7 days revealed no behavior changes or ocular complications in any of the 3 study groups. Pathologic analysis of the corneas revealed normal findings on all groups without signs of inflammation, fibrosis, or any other abnormality, and no difference between the treated and control eyes. CONCLUSIONS: The findings of this study suggest that the use of topical perchlorate is safe to use on eyes in high concentrations. The efficacy of this compound in minimizing fibrosis of the nasolacrimal sac and duct warrants further study.