On 08apr2022, a patient (pt) called to report while wearing 1-day acuvue® moist® brand contact lenses (cls), the pt experienced difficulty ¿clicking¿ apart the lens packages from the foil strip causing the foil to tear.The pt advised the foil would ¿sometimes tear¿ on more than one package causing the solution to dry up.The pt reported a diagnosis of corneal ulcers in both eyes in (b)(6) 2022 because the pt may have used a cl that may not have been sterile due to this issue.The pt called an eye care professional (ecp) in (b)(6) 2022 due to pain in both eyes (ou) with ¿a feeling of something in her eyes as if they were scratched¿ and was diagnosed with ou ulcers over the phone.Two prescription eye drops (medication is unknown) were called in by the ecp for use in both eyes for 10 days.The pt reported both eyes felt better within 2-3 days, but continued to use the drops for 10 days.The pt reported wearing cls daily from ¿6am to 12am¿ and both eyes dry out from ¿looking at the computer all day.¿ the ecp advised the pt to wear glasses more often to give the eyes a break from cl wear.The pt stated both eyes have ¿been fine¿ since january and did not know if the ulcers were related to the packaging issues.The pt declined to provide ecp contact information and refused to provide any additional information.This event will be submitted as an od worst-case event as we were unable to verify the pt¿s diagnosis and treatment with the ecp.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 6125310110 was produced under normal conditions.This report is for the pt¿s od event.The report for the pt¿s os event will be filed as a separate report.The suspect od cl was not available for return for evaluation.No additional evaluation can be conducted.No further information is expected.If any further relevant information is received, a supplemental report will be filed.
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