Kulzer north america was notified of this incident by global safety manager at kulzer (b)(4) (manufacturer).Patient was seen at dental office for dental procedure.Doctor applied gluma intraorally.During gluma application material accidentally got in patients 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, 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 burning.Subsequent follow up with patient confirmed she is 100% healed and asymptomatic.This material is known to be caustic to soft tissue.This is mitigated in our ifu as we state that safety goggles and the use of rubber dam to protect soft tissues and eyes.In this case neither were utilized per patient.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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