On (b)(6) 2018 a patient (pt) called to report a diagnosis of corneal ulcer od while wearing the acuvue vita brand contact lens.The pt reported the lenses are tearing after one day of wear.Pt went to an eye care provider (ecp) who diagnosed the od corneal ulcer (date of visit was unknown) and reports a follow-up visit tomorrow.Pt reported wearing a 1 week trail of the acuvue vita brand contact lenses without issue, but reports the lenses tearing since (b)(6) 2018.Pt could not recall the date of the recent corneal ulcer event.No additional medical information was received.On 31may2018 a call was placed to the pts ecp and a representative provided additional information: -pt reported the acuvue vita brand contact lenses had been tearing soon after opening a new contact lens package.Pt was diagnosed with an od corneal ulcer on (b)(6) 2018.The pt was refit with a competitor brand contact lens on (b)(6) 2018 and allowed to return to contact lens wear.No additional medical information was provided.Multiple attempts were made to contact the pt for additional information, but no additional information has been received.It is unknown if the suspect lens is available for return for evaluation.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 b00mdk8 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.
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