It was reported on 20dec2019 via email that a consumer experienced an irritated, watery, and red right eye on (b)(6) 2019.It was also reported that the eye affected was only the right eye.The consumer sought medical attention on (b)(6) 2019 and was diagnosed with corneal infiltrate/ulcer.The consumer was prescribed with moxifloxacin every two hours for the first two days then tapered to four times a day for five days.It was reported that the symptoms have resolved.
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H.3., h.6.: the actual complaint product was not returned for evaluation.The investigation included a review of the complaint history/trend, manufacturing records, component nonconformance history, nonconformance history, in process sampling/control information, equipment logbook, sterilization, retain sample inspection, and training deviations.There were no deviations that would contribute to the nature of the complaint.The lot met release criteria and is acceptable for continued distribution.Per the sterilization effectiveness memo, due to the sterilization cycle used to produce contact lenses, it can be concluded that any infection of the eye suffered by patients using lenses that have been terminally sterilized and are taken from an intact primary package cannot be the result of any organism originating from that package.There were no nonconformance identified related to sterilization of the complaint lot.In addition, the consumer did not indicate any leaking packages or that there was no saline in any package or any other seal related events, no sealing related defects were identified during any in process inspections of the complaint lot, nor during final inspection of the complaint lot.No root cause was able to be identified based on the manufacturing conditions as all processes were reviewed and found to be within specifications.The manufacturer internal reference number is: (b)(4).
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