Model Number 550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Capsular Bag Tear (2639)
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Event Date 12/29/2022 |
Event Type
Injury
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Event Description
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A customer reported experience a posterior capsule tear/rupture resulting in a vitrectomy in an unknown eye of a patient, during surgery.
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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.Alcon lensx (site #3008772169) is no longer operational.Lensx manufactured products are maintained and investigated by the alcon research, ltd.Irvine technology center site #2028159).The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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All 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.The company representative did not confirm nor replicate anything that would have contributed to the reported event.The system was tested and found to meet product specifications.An internal investigation was opened to address this issue but was later determined to be irrelevant to this investigation.The system was found to meet specifications.Therefore, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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