ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065750469 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/28/2022 |
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 nurse reported that when patient was undergoing a phacoemulsification with intraocular lens implant for left eye cataract removal.During a critical point in the procedure the tubing disconnected from the ophthalmic consoles handset and a sudden shallowing of the anterior chamber occurred.The equipment was inspected and tested to be working again the surgeon noted a posterior capsule rupture.An anterior vitrectomy was then preformed.
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Manufacturer Narrative
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The product under investigation is not a serviceable device.Therefore, a service record review was not performed.There was no equipment returned for this investigation.Based on the information obtained, the root cause of the reported event is inconclusive.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.No similar complaints were reported for the product lot/batch/serial under investigation.Based on the information obtained, 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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