The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection and dimensional analysis.The inlay was received in a dirty contact lens case and the findings revealed the presence of a cut and some particles and fibers on the inlay surface.The edge thickness and diameter were measured and found to be within specifications.The condition of the inlay is suspected as being caused by removal from the eye, handling, and improper storage during transport.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Corneal haze and decreased vision are listed in the device labeling as known potential risks.(b)(4).
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