On (b)(6) 2019 a patient (pt) in (b)(6) called to report discomfort and ¿soreness¿ in both eyes (ou) on (b)(6) 2019 while wearing the 1-day acuvue® trueye® brand contact lenses.Pt went to the eye care provider (ecp) on (b)(6) 2019 and was diagnosed with keratitis ou.Pt was prescribed antibiotic pills, anti-inflammatory pills, and an eye drop (medication names were not provided).The pt reported the eye drop was used 6 times a day.On (b)(6) 2019 a call was placed to the pt and additional information was provided.Pt was prescribed flumetholon ophthalmic suspension 0.02%, quinovit eye drops and tearing eyes lubricant 6 times daily.Pt has not yet been cleared by the ecp to return to contact lens wear.The pt refused to provide the medical report.The suspect contact lenses were discarded.This report is for the right eye (od) event.A separate report will be filed for the left eye (os) event.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot 5821840103 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.
|