Sealed device(s) returned in unused condition were within manufacturing specification, free from any faults or failures.The open device returned in used condition was damaged and could not be evaluated, no root cause for the damage could be identified.Record review found no issues, nonconformances, or trends.The relationship between the coopervision device and the incident is unconfirmed.As patient was using a different device in each eye and it is unknown which or both eyes were involved, both devices are being reported.Please refer to manufacturer report (b)(4) 9614392-2023-00011.
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This incident was reported by the optician to the manufacturer.It was reported that the patient experienced torn lens in the eyes and sought medical treatment.Alleged that the patient was diagnosed with eye infection and was treated with unspecified antibiotics and lubricant.The issue was resolved in seven (7) days.Good faith efforts have been made to obtain further information without success.As of the date of this report, additional information is unknown.This event is being reported in an abundance of caution due to the unknown type or severity of the alleged infection and lack of supporting medical information.Should further information become available, a follow-up report will be submitted as appropriate.
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