MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number ASKU

Device Problems Excess Flow or Over-Infusion (1311); Failure to Shut Off (2939)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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: (b)(4).

Event Description

A customer reported that during surgery an ophthalmic handpiece exhibited continuous irrigation.Swapping the handpiece seemed to resolve the issue.There was no report of any patient harm.Additional information has been requested.

Manufacturer Narrative

Corrected information was provided in section b.2 which was missed in supplemental report 01.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The initial decision to report was incorrect resulting in the initial report being submitted in error.This report does not meet criteria for reporting as a device malfunction.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received has clarified the ophthalmic handpiece (hp) is a irrigation/aspiration hp.The event occurred during the i/a mode.The i/a hp was exchanged and the issue was resolved.

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 12651565
• MDR Text Key: 277182605
• Report Number: 2028159-2021-01195
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 10/18/2021; 10/20/2021
• Supplement Dates FDA Received: 10/20/2021; 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM