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

Catalog Number 8065751763

Device Problems No Display/Image (1183); Unexpected Shutdown (4019)

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.(b)(4).

Event Description

A customer reported that during a surgery an ophthalmic console was shutting down with gray screen on display and the power button turned amber.System restarted after holding the power button.Procedure details and patient impact were not reported.Additional information has been requested none received till date.

Manufacturer Narrative

Additional information was provided in sections d.9, h.3, h.6 and h.10.The company service representative examined the system and was unable to confirm or replicate the reported event.As a preventative measure, the host, and the multifunction input output (mfio) printed circuit board (pcb) were replaced.The system was then tested and met all product specifications.The host was received, and a visual assessment of the returned sample revealed no obvious nonconformities.The host sample was installed into a calibrated console and there were no advisory messages during startup.The sample passed all functional tests, and the reported event could not be replicated, and the host was working as intended.A system manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The system was found to meet specifications; therefore, 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).

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14267028
• MDR Text Key: 290548299
• Report Number: 2028159-2022-00582
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657517633
• UDI-Public: 00380657517633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1