ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
|
Back to Search Results |
|
Model Number TABLETOP |
Device Problem
Gas Output Problem (1266)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/04/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr, part 803, when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
A physician reported, that ophthalmic operating console was not dispensing sulphur hexafluoride gas.And gas bubble in patient eye was reduced to unusual size, it was noticed on post operative day eight.There were no details of the procedure.There was no report of the patient harm.Additional information has been requested.None received till date.
|
|
Manufacturer Narrative
|
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 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.A potentially relevant complaint was found and reviewed as part of this investigation.The system was found to have no problem.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).
|
|
Search Alerts/Recalls
|
|
|