Catalog Number 8065751763 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
Capsular Bag Tear (2639)
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Event Date 10/04/2022 |
Event Type
Injury
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Event Description
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A customer reported that during a cataract surgery, while using an ophthalmic operating console air bubbles entered the eye and the patient experienced capsule rupture.There was no further procedure required and the symptoms were resolved.There was no patient harm.
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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 batch/lot/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 lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The complaint was opened for the first case of capsule rupture reported by the customer on the same day of surgeries.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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