Catalog Number 8065753041 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/30/2021 |
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 physician reported that during a vitrectomy surgery, a patient experienced hypotony which lasted less than a minute and resulted in a large suprachoroidal hemorrhage.The surgeon completed the retinal detachment repair, close the globe with suture and left the intraocular pressure (iop) slightly firm.The patient's retina was attached at last visit and the suprachoroidal hemorrhage was improving.
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Manufacturer Narrative
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A service record was opened on to address the reported event.The system was replaced due to customer request.A system manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.The root cause of the reported event is inconclusive.The manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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