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

Catalog Number 8065751763

Device Problem No Device Output (1435)

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 health professional reported that an ophthalmic surgical console exhibited no phacoemulsification power.The issue was resolved after the system was rebooted.Procedure details and patient involvement information is unknown.There was no report of any patient harm.Additional information has been requested.

Manufacturer Narrative

The company service representative examined the system and was unable to confirm or replicate the reported event.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to user error.The 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).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 12285254
• MDR Text Key: 265363069
• Report Number: 2028159-2021-00853
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657517633
• UDI-Public: 00380657517633
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

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: 8065751763
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1