On (b)(6) 2018 the patient (pt) called and provided additional medical information: pt can¿t recall the exact date of event, but confirmed it was in (b)(6) 2018.Pt reported ¿the eyes were kinda bothering the pt¿ so the pt removed the lenses that night.The pt reported that the eye care provider (ecp) told the pt that while removing the od suspect lens, the pt ¿removed about 70% of the cornea¿ and diagnosed the pt with corneal epithelial erosion.Pt reported the ecp advised that ¿it went down to the root.¿ pt was prescribed ketorolac for pain every 3 hours and an antibiotic eye drop (name of the eye drop was not known) every 4 hours for at least 5 days.The pt was unsure how long the eye drops were prescribed.The pt could not recall how many days the suspect lens had been worn at the time of the event, but reported the ¿lenses tend to get stiff around 2 weeks and the pt will have to replace them¿.The pt reported using biotrue contact lens solution and does not sleep in the lenses.The pt reported the lenses have not been lasting the month.The pt had an eye exam yesterday and refit into acuvue oasys brand contact lenses.Pt reported vision was bad in the od after the event and pt thought he/she was going ¿blind¿, but the vision improved after about 5 days and pt reports it is fine now.On (b)(6) 18 a call was placed to the pts ecp and a representative provided additional medical information: the representative reported the pts first visit was on (b)(6) 2018.Pt was diagnosed with corneal erosion od; pt was prescribed ketorolac qid, blink tears, and ocuflox qid.Pt had a follow up visit the following day and advised to continue medications for 4 more days and follow up.Pt had an additional follow-up visit on 05feb2018 and advised to continue treatment and to lubricate eyes well with the blink tears, use 6 times a day.The pt was seen for a follow-up visit yesterday and advised to discontinue the ketorolac and ocuflox, but to continue the blink tears; no indication in the pts chart that states pt has permanent damage or scarring; pts has a new prescription for acuvue oasys brand contact lenses.No additional medical information was provided.The suspect lens was discarded.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 b00mztx was produced under normal conditions.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.(b)(4).
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