On (b)(6) 2018 an eye care provider (ecp) in (b)(6) reported a patient (pt) had red and swollen eyes while wearing the 1-day acuvue moist brand contact lens.
On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt reported discomfort after wearing the lens ou for a ¿period¿.
The symptoms continued after the suspect lenses were removed.
The following day the pt presented to the ecp and was diagnosed with keratitis.
The pt was prescribed tobramycin-dexamethasone 5-6 times a day until recovery.
The pt reported the eyes have not yet recovered.
The event date was reported as (b)(6) 2018.
On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt reported the eyes were still red, but not painful.
Pt can¿t use this contact lens any longer.
On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt has not been back to the ecp for a follow-up visit, so pt is unsure if the keratitis ou has resolved.
Pt reported ou redness but has no eye pain.
Pt continues to apply the tobramycin-dexamethasone eye drops ou and follows the recommended dosage.
On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt reported the eyes felt better, but ou redness remains.
Pt stated the ecp advised the redness will resolve gradually with rest.
The pt continues to apply the tobramycin-dexamethasone eye drops as previously prescribed.
The pt has not been back to the ecp for a follow-up visit, but will return to the ecp if the symptoms do not resolve.
This report is for the left eye (os) event.
A separate report will be filed for the right eye (od) event.
The suspect lens 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 5170830104 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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