Model Number 610-0001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Loss of Vision (2139)
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Event Date 10/24/2017 |
Event Type
Injury
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Manufacturer Narrative
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The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection and dimensional analysis.The edge thickness and diameter were measured and found to be within specifications.Cuts and particles were observed on the device, but these findings are consistent with findings for corneal inlays that have been explanted since surgical instruments are required to remove the device from the eye and place it in a hydrated storage container for 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.Decreased visual acuity is listed in the device labeling as a known potential risk.(b)(4).
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Event Description
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The patient underwent uneventful implantation of the raindrop corneal inlay in the right eye on (b)(6) 2017.The inlay was explanted on (b)(6) 2017 in order to address decreased best corrected distance visual acuity (bcdva) from 20/15 (preoperatively) to 20/40+2.Post explant, bcdva improved to 20/30.The reason for decreased vision remains unknown.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Patient follow-up was requested from the surgeon, who provided the following additional information.The patient was last examined on (b)(6) 2017 and the best corrected distance visual acuity (bcdva) had improved to 20/20-1.
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Search Alerts/Recalls
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