ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION
|
Back to Search Results |
|
Catalog Number 8065752914 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hyphema (1911); Intraocular Pressure Increased (1937); Iritis (1940); 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
|
A health care professional from a clinical study site reported that the patients experienced postoperative complications of anterior chamber flare, anterior chamber cells, anterior chamber bleeding, hyphema, choroidal leakage, high intraocular pressure and received pharmacological or surgical interventions during the use of console and handpiece.All the patients from clinical study were underwent cataract and vitrectomy combination surgeries.
|
|
Manufacturer Narrative
|
Specific product identifiers (serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this serial number cannot be performed as the serial number is unknown.The serial is unknown.Therefore, a service history review cannot be performed.Based on the information obtained, the root cause of the reported event is inconclusive.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).
|
|
Search Alerts/Recalls
|
|
|