Model Number 610-0001 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Corneal Abrasion (1789); Visual Impairment (2138); Loss of Vision (2139)
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Event Date 12/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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The device history record (dhr) for this manufacturing lot was reviewed and the device met all release criteria and there were no discrepancies or unusual findings that relate to the reported event.The explanted inlay is discarded by the facility and is not available for evaluation.This mdr is being filed for the 4th corneal inlay device that was implanted on (b)(6) 2016 and explanted on (b)(6) 2016; reference mdr # 3005956347-2016-00008 for the 1st raindrop corneal inlay that was implanted on (b)(6) 2016 and explanted the same day; reference mdr # 3005956347-2016-00009 for the 2nd raindrop corneal inlay that was implanted on (b)(6) 2016 and explanted on (b)(6) 2016; reference mdr # 3005956347-2017-00012 for the 3rd raindrop corneal inlay that was implanted on (b)(6) 2016 and explanted on (b)(6) 2016.(b)(4).
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Event Description
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A raindrop corneal inlay was implanted in the patient's left eye on (b)(6) 2016.Prior to this implantation, three raindrop inlays were implanted and removed due to inlay decentration and corneal flap not holding inlay in place.At one-day postoperative visit, this fourth inlay decentered and was subsequently explanted on (b)(6) 2016.The patient's preoperative best corrected distance visual acuity (bcdva) in the operative eye was 20/20.Prior to intervention, bcdva decreased to 20/300.After intervention, the patient's bcdva improved to 20/30.
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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.During this exam, the patient complained of decreased distance vision in comparison to preoperative distance vision.The patient's best corrected distance visual acuity (bcdva) has returned to baseline (20/20).Trace epithelial ingrowth was observed, cornea was clear with minimal debris but no haze.Corneal topography showed irregular astigmatism which was not a preexisting condition for this patient.The patient was recommended to use artificial tears a couple of times a day.
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Search Alerts/Recalls
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