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

Catalog Number 8065751762

Device Problems Device Alarm System (1012); Computer Operating System Problem (2898)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2020

Event Type  Injury  

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 surgeon reported a system message code was displayed at the start of the cortex removal of a routine cataract extraction procedure.The system was rebooted and a new handpiece was primed and tuned, but this did not resolve the issue.The surgeon was not able to complete the case.The incision was sutured with the cortex in situ.The patient was treated with anti-inflammatory medication to mitigate inflammation caused by retained cortex tissue in capsular bag.The patient will require a second procedure for removal of the retained cortex and implantation of the intraocular lens.

Event Description

Additional information has been received which indicated the patient has undergone the second surgery on the (b)(6) 2020 to remove the cortex and implant a lens.He is now doing fine.

Manufacturer Narrative

Additional information has been provided in b.5.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information has been provided in d.4., h.4., h.6.And h.10.A new footswitch was sent to the customer to resolve the event reported.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported events could not be confirmed.The root cause cannot be determined conclusively.The manufacturer internal reference number is:(b)(4).

Manufacturer Narrative

Additional information has been provided in d.10., h.3, h.6.And h.10.The original footswitch was returned for evaluation.A visual assessment of the returned sample found no visual nonconformity.The returned footswitch was connected to a calibrated system.The system was able to boot-up without issue.The footswitch was tested per service test procedure (stp) and was found to meet specifications.Root cause the root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, FOOTSWITCH
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9902691
• MDR Text Key: 187369313
• Report Number: 2028159-2020-00301
• 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,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751762
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 04/03/2020; 05/06/2020; 11/24/2020
• Supplement Dates FDA Received: 04/16/2020; 05/14/2020; 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION ACTIVE SENTRY HANDPIECE
• Patient Outcome(s): Required Intervention