ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)
|
Back to Search Results |
|
Catalog Number 8065752450 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
An ophthalmic surgeon reported the vitrectomy cutter shaft was protruding out from the base of the cutter during procedure.There was no patient harm.
|
|
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).
|
|
Manufacturer Narrative
|
A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
The opened probe returned for evaluation was not within the final lot number reported, based on radio frequency identification (rfid) tag identification.Therefore, no sample evaluation was performed.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.Since the sample associated with the reported product and lot number was not received at the manufacturing site, the root cause for the customer complaint issue cannot be determined.The returned sample was not within the final lot number, based on radio frequency identification (rfid) tag identification.Therefore, specific actions with regard to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut ,during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed, associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|
|
|