[187459850]
(b)(4). Initial reporter? S phone number: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187459851]
On 17dec2019 a patient (pt) in (b)(6) reported irritation (affected eye was not provided) while wearing the acuvue? 2? Brand contact lenses (cls). The pt went to an eye care provider (ecp) and advised? It was found to be contamination by bacteria.? The pt was treated by the ecp and recovered. On 19dec2019 the pt provided additional medical information: pt experienced redness ou on (b)(6) 2019 after 1 day of cl wear. The pt went to the ecp on (b)(6) 2019 and prescribed vigamox 1 drop ou q 2 h for 5 days. The pt reported the eyes are better at the moment, but has not returned to cls wear. The pt reported the ecp advised the? Eyes were full of bacteria? , but the pt couldn? T recall if the ecp mentioned the diagnosis as? Bacterial infection.? The pt reported a fu ecp visit tomorrow ((b)(6) 2019). The pt reported daily lens wear with a monthly replacement schedule. On 20dec2019 a call was placed to the pt who provided additional medical information: the pt reported ou discomfort on (b)(6) 2019 while wearing the suspect lenses. The pt also reported irritation, redness, swelling and tearing ou. The pt went to the ecp at an emergency clinic on (b)(6) 2019 and was advised the ou were? Hurt and inflamed.? The pt was prescribed vigamox every 2 hours for 5 days. The pt did not advise the diagnosis was due to? Bacterial infection.? The pt had a fu visit (b)(6) 2019 and medication was changed to maxinon (dexamethasone, neomycin, polymyxin b) tid for 3 days, then bid for 3 days, then once daily for 3 days. Pt was advised to use optive as needed. Pt has fu ecp visit in (b)(6) 2020. The pt reported both eyes are currently fine. On 20dec2019 a call was placed to the pts treating ecp and additional information was requested. A representative is unable to provide medical information. An email was sent to the pts treating ecp and additional medical information was requested. On 20dec2019 a call was placed to the pts treating ecp regarding the fu ecp visit. A representative confirmed the date of the fu visit on (b)(6) 2019; pt was prescribed optive and maxinon. No contraindication for the pt to return to cls wear. No additional medical information was provided. On 23dec2019 an email was received from the pt who confirmed the date of the event to be (b)(6) 2019. The pt reported also presenting for medical care on (b)(6) 2019 and (b)(6) 2019. No additional medical information has been received. The od suspect cl was requested for return for evaluation, but has not been received. This report is for the pts od event. The report for the pts os event will be submitted in a separate report. 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 b00qsmd was produced under normal conditions. If any further relevant information is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: D, B5