The patient herself contacted kulzer (b)(4) (manufacturer) via our e-mail hotline: (b)(4).The global safety manager was informed the same day and informed the next day kulzer (b)(4) with all given contact data.(b)(4) contacted the patient and evaluated the following information: patient was seen at dental office for a dental procedure.Doctor applied gluma desensitizer intraorally.During gluma application the liquid material accidentally got in patient's eye through splatter.Doctor had patient flush eye immediately with water for approximately 20 - 30 minutes.Patient was wearing contacts which she removed half way through flushing.Patient called ophthalmologist prior to departing dental office.Ophthalmologist instructed patient to use artificial tears every hour for 24 hours.Patient followed up next day with ophthalmologist; the office was confident there were not injuries caused to the eye due to the patient being asymptomatic and experiencing no vision changes.Due to the immediate attention needed for gluma contact in the eye, gluma was left in the mouth the entire time causing burnings.Subsequent follow up with patient confirmed she is 100% healed and asymptomatic.This desensitizing liquid is known to be caustic to soft tissue.This could be avoided by ifu recommended measures, as we state there the necessity to use safety goggles and rubber dam to protect soft tissue and eyes.In this case neither were utilized per the patient's given information.This will be reported to maintain compliance with 21 cfr part 803 as if this were to recur, it could very likely cause permanent eye damage.Also being reported out of an abundance of caution.
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