Catalog Number 8065751763 |
Device Problems
Complete Blockage (1094); Suction Failure (4039)
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Patient Problems
Prolapse (2475); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/09/2023 |
Event Type
Injury
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Event Description
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A physician reported that during a cataract surgery while using an ophthalmic console aspiration failure happened and the patient experienced capsular rupture with vitreous loss in anterior chamber also pieces of lens had dropped into the posterior segment.The surgeon has performed vitrectomy with scissors in order to seal the incisions.The patient will be reoperated very soon.Additional information was received clarifying that the console was having some occlusion issue as well.
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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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Manufacturer Narrative
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The company representative did not confirm nor replicate the reported event.The system was tested and found to meet product specifications.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A 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.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.Posterior capsule tear is an issue that is occasionally reported with cataract surgery.However, a review of the complaint trends shows that the frequency reported is within known levels for this event.The system was found to meet specifications.Therefore, the root cause of the reported event is inconclusive.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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