Catalog Number 8065751763 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Clouding/Hazing (1878); Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/18/2023 |
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 during a cataract surgery in the beginning of nucleus removal, while using an ophthalmic console and phacoemulsification handpieces an occlusion tone was heard and two patients experienced corneal burns.As the injury would result in leakage, the wound was sutured.A mild corneal opacity was observed on patients.Additional information has been requested but none received till date.This report is for the ophthalmic operating console involved in this event.
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Manufacturer Narrative
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The company representative was unable to confirm nor replicate anything that would have contributed to 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 serial number was performed.No similar complaints were reported for the product serial under investigation.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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