[187461704]
(b)(4). Initial reporter? S phone number: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187461705]
On 18dec2019, a patient (pt) in (b)(6) reported a diagnosis of a corneal ulcer? Caused by an infection or bacteria? In the os while wearing an acuvue? Oasys? For astigmatism brand contact lens (cl). After a few days of wear, the pt awoke with os redness and discharge. The pt visited an eye care provider (ecp) and was diagnosed with a? Corneal ulcer caused by an infection or bacteria from wearing cls.? The pt is still in treatment and unable to return to cls wear for another month. No further information was provided. On 19dec2019, additional information was received from the pt: in (b)(6) 2019, the pt experienced discomfort inserting the suspect os cl, but no issue upon removal. After 4 days of wear, the pt awoke with redness and discharge in the os. The pt visited the ecp on (b)(6) 2019 and was diagnosed with os corneal ulcer. The ecp advised the pt that? It could be a bacterial infection. " the pt was prescribed zymar every hour for 7 days; and hyback lubricating drop as needed for discomfort. The pt? S treatment was changed the same evening (due to an allergic reaction to zymar causing eyelid pain and swelling os) to tobracyn every 6 hours for 7 days; hyabak as needed; and regencel every 8 hours for 7 days. The pt returned to the ecp on (b)(6) 2019 and was advised to continue treatment. The pt returned to the ecp on (b)(6) 2019 and advised the os was almost healed. The pt was told to continue tobracyn every 4 hours for 3 additional days, discontinue regencel, and return to cl after 30 days of cl rest. The pt reported the os is currently okay. The pt reported daily wear with 30-day replacement scheduled. The pt uses opti-free pure-moist to clean cls. On 19dec2019, an email was received from the pt with attached prescriptions: prescription dated (b)(6) 2019, zymar 1 gtt, os 1/1 until return; hyabak or optive 1 gtt every 1 hr; cold compresses for relief. Return in 48 hrs. Prescription dated (b)(6) 2019, regencel cream apply to affected every 8 hrs for 7 days; tobracin every 6 hrs for 7 days; hyabak 1 gtt to affected eye every 12 hours continuous use. Review in 24 hrs. Multiple attempts were made to contact the treating ecp for additional information, but no further information was received. The suspect os cl 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 b00s1vf 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