ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
|
Back to Search Results |
|
Model Number TABLETOP |
Device Problem
Failure to Cut (2587)
|
Patient Problems
Retinal Tear (2050); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
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).
|
|
Event Description
|
The customer reported during a posterior vitrectomy, the vitreous cutter of an ophthalmic operating console malfunctioned (not cutting, appeared to be pulling and tearing retina).The console settings were verified, and the pressure values were verified.The vitrectomy probe was exchanged with no resolution.The customer was unable to reboot the system as the eye needed to be continuously pressurized.No system message (sm) was displayed.The procedure was aborted.Additional information has bee requested but none received till date.
|
|
Manufacturer Narrative
|
No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr) opened.The system found to meet all cosmetic and performance standards per the service test procedure (stp).A system 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.A potentially relevant complaint was found and reviewed as part of this investigation.The root cause cannot be determined conclusively.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
|
|
|