As initially reported by the consumer via email, the consumer wore the contact lenses for six hours, she had to remove them and consulted a doctor the following day.The doctor told her that the contact lenses left ulcers on both eyes (ou) associated with burning sensation.It was also reported that the consumer was prescribed with unspecified eye drops (treatment regimen unknown).At the time of report, the consumer's current eye status is unknown.Additional information was requested but not yet received.
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Additional information received from the consumer on (b)(6) 2017 via fda medwatch form to the us medical safety stating that the contact lenses were worn three times.The first two times the contact lenses were worn for about three hours, it resulted to the eyes feeling dry.The third time the contact lens was worn for six hours, it turned the eye red and irritated.The consumer reported that the eyes burned and she had trouble seeing after of the contact lenses were removed.The consumer reported that sumatriptan was being used daily and norgestimate and ethinyl estradiol was used as needed along with fexofenadine.Additional information received from the consumer on (b)(6) 2017 via email noted that there were four contact lenses available for investigation.It was reported that the discomfort resolved when lenses were removed, however, the burning sensation and redness were experienced for a week, and the dry sensation for few weeks.The consumer sought for medical attention on the dates as follows: (b)(6) 2017 and (b)(6) 2017.The reported diagnosis was 'ulcers caused on both eyes because of contact lenses that left scarring on both eyes' and the consumer was prescribed with neomycin, polymyxin, dexamethasone opthalmic solution with unknown treatment regimen.Additional information has been requested but not yet received.
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