On (b)(6) 2018 an email was received from a patient (pt) who reported about two months ago both eyes became very irritated and ¿infected¿ while wearing the 1-day acuvue define with lacreon brand contact lenses.Pt reported pt ¿had to 6 weeks off of contacts entirely¿.On 10jul2018 a call was placed to the pt and additional information was provided: pt was diagnosed with uveitis ou 2 months ago ((b)(6) 2018) while wearing the suspect 1-day acuvue define with lacreon brand contact lenses.Pt reported light sensitivity, irritation, tearing, discharge ou and went to an eye care provider (ecp).Pt was advised to discontinue contact lens wear and prescribed a steroid eye drop tid and liquid tears.Pt advised the event resolved and was cleared to return to contact lens wear.The pt was given trial lenses in acuvue oasys brand contact lenses.Pt is interested in finding a daily wear colored lens.Pt reported both eyes are currently fine.At the time of the call the pt didn¿t have the treating ecp contact information for additional information.On 01aug2018 an email was received from the pt with additional information: the pt provided the name of an ecp, but no contact information.The pt reported a possible return visit to the ecp provided.An internet phone search was conducted for the ecp contact telephone number.A call was placed to the ecp¿s office, but it was disconnected.Correct ecp contact information was requested from the pt, but nothing additional has been received.This report is being submitted for the pt¿s od as a worst-case event as the diagnosis and treatment were unable to be verified by the treating ecp.The report for the pt's os will be filed in a separate report.The lot is unknown, and the suspect lens was discarded.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.
|