Model Number 600-0032 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Corneal Clouding/Hazing (1878)
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Event Date 09/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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The site is being contacted to clarify whether the device is available for evaluation.The review of the device history record is underway and will be reported in a follow-up report.Corneal haze is listed in the device labeling as a known potential risk.Complaint reference #: (b)(4).
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Event Description
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The subject was enrolled in a foreign clinical trial and underwent implantation of the investigational raindrop corneal inlay in the left eye on (b)(6) 2016.The study involved the use of mitomycin-c and concurrent lasik in the operative eye.Six months postoperatively the patient presented with faint central corneal haze that recurred 9 months postoperatively and again 15 months postop.Immediately prior to explant on (b)(6) 2017, the corneal haze was central, grade 1/trace.The surgeon believes that extended debris in the corneal flap contributed to the development of haze.Best corrected distance visual acuity was not measured at the onset of corneal haze or immediately prior to inlay explant, so the impact on vision is unable to be characterized.The patient is scheduled for examination at 1-month and 3-months post inlay removal.
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Manufacturer Narrative
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The device history record (dhr) review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.(b)(4).
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Event Description
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Patient follow-up was requested and the following information was received.At 3-months post inlay explant visit, the patient's best corrected distance visual acuity (bcdva) is 20/20 and the corneal haze has resolved.
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Search Alerts/Recalls
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