Catalog Number AS71057-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Edema (1791); Endophthalmitis (1835); Uveitis (2122); Blurred Vision (2137)
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Event Date 07/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that a patient experienced postoperative endophthalmitis after the procedure.The patients current condition is unknown.Additional information was requested; however, none has been received to date.
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Event Description
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Additional information was provided by the surgeon who indicated the patient had undergone a femtosecond laser-assisted cataract procedure on the left eye.Three days postoperatively, the patient presented with decreased vision.The vision had decreased to hand motion (hm) at one foot, the anterior chamber had cells and fibrin present.The patient was referred to a retinal specialist who performed a vitrectomy, anterior chamber debridement, with intra-vitreal antibiotics injections.A culture was taken and was positive for staphylococcus epidermidis [staph epi].Twenty-one days postoperatively from the initial procedure, the surgeon indicated the patient's vision improved to 20/40, the eye demonstrated mild corneal edema and the patient's current condition was improving.The surgeon indicated the manufacturer's product(s) did not cause or contributed to the event.
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Manufacturer Narrative
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Additional information provided in a.1., a.2., a.3., b.2., b.3., b.5., b.6., d.10., h.6., and h.10.Following submission of the initial report, the reported event is no longer reportable as the surgeon indicated he is not blaming our product.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Correction provided in h.10.Additional information provided in b.2.And e.1.In the previously submitted supplemental medical device report.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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