Model Number 610-0001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Scar (1793); Corneal Clouding/Hazing (1878)
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Event Date 10/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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The explanted inlay was discarded by the facility and is not available for evaluation.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 is listed in the device labeling as a known potential risk.Complaint reference number: (b)(4).
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Event Description
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The patient underwent implantation of the raindrop corneal inlay on (b)(6) 2017.On (b)(6)2017, the inlay was explanted in order to address recurrent corneal haze.Additional information has been requested.
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Manufacturer Narrative
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Corneal scarring is listed in the device labeling as a known potential risk.(b)(4).
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Event Description
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The following new information was provided by the surgeon.The patient underwent uneventful implantation of the raindrop corneal inlay in the right eye on (b)(6) 2017.On (b)(6) 2017 a minor scar was observed on the central cornea.On (b)(6) 2017, there was no scarring visible, but there was peripheral edge haze.The inlay was explanted on (b)(6) 2017.
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Search Alerts/Recalls
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