Catalog Number 8065753057 |
Device Problem
Suction Failure (4039)
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Patient Problems
Corneal Edema (1791); Prolapse (2475)
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Event Date 02/05/2024 |
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 cataract surgery on the right eye of the female patient an ophthalmic handpiece was not able to remove viscoelastic, physician had to exit and re-enter the eye and press on the foot ped for a while to begin removal.When the surgery proceeded, during phacoemulsification, the entire anterior chamber was collapsing on itself, allowing the lens to move forward in the bag towards the cornea.The eye had to be refilled with balanced salt solution and viscoelastic to allow the surgery to proceed.The surgery took much longer than expected to avoid a complication.Patient condition was corneal edema and the patient would be seen in normal follow up.
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Manufacturer Narrative
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The company representative was unable to 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.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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