ALCON RESEARCH, LTD. - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)
|
Back to Search Results |
|
Catalog Number ASKU |
Device Problems
Leak/Splash (1354); Device Dislodged or Dislocated (2923)
|
Patient Problem
No Code Available (3191)
|
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 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: 2016-24036.
|
|
Event Description
|
A customer reported frequent issues with leaking trocars.All procedures were completed; during some procedures, trocar plugs were used to prohibit the flow.The reporter informed that patient harm details are difficult to assess, but suggest that risk of airline induced scotoma, lens dislocation and viscoelastic retention possible.Additional information and product samples have been requested.
|
|
Manufacturer Narrative
|
No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.No sample has been returned for evaluation for evaluation; therefore, the condition of the product could not be verified.Due to an observed increased trend for this event, an internal investigation was initiated to determine if corrective and preventative actions were necessary.A root cause for the increased complaint rate was found to be related to a manufacturing post assembly inspection practice.This complaint does not identify a reported lot and no sample was returned for evaluation so it cannot be determined if the complaint can be attributed to the post assembly inspection.The post assembly inspection has been discontinued and an effectiveness check has been established and will be monitored periodically.(b)(4).
|
|
Search Alerts/Recalls
|
|
|