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

Model Number TABLETOP

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 01/29/2020

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 surgeon reported iop (intraocular lens pressure) compensation was not activated during the procedure.Patient harm was not reported.Additional information has been requested.

Manufacturer Narrative

Additional information has been provided d.10, h.3, h.6, and h.10.The system was examined.The company representative did not indicate finding any issues that would be associated with the reported event.However, a system message (sm) ¿infusion flow data invalid: intraocular pressure (iop) control functions will be disabled.Check infusion tubing for air bubbles¿ was found in the event log, which is consistent with the reported issue.The fluidics module and the tray arm were both replaced as a preventive measure.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to have met specification.Therefore, the root cause of the reported event cannot be determined conclusively.No further information was able to be obtained from this customer with regards to the consumable.With no additional, related information provided, the customers reported event was not able to be confirmed.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received indicating that the issue occurs randomly.It occurs at the beginning, in the middle or at the end of the procedure.Iop compensation is activated but shuts itself off during the procedure for several seconds.This is noticed by the surgeon when the eye becomes soft.The surgeon discontinues suction and then the iop compensation reactivates on its own.Hypotony lasts a few seconds.There have been no long-term clinical consequences.

Event Description

Further information was received indicating that priming was completed before the procedure began.There is no indication of the tubing being kinked, modified or taped to something.No blockages or flow issues were observed with tubing.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The system was examined.The company representative did not indicate finding any issues that would be associated with the reported event.However, the system messages were confirmed (via event log review) and the fluidics module was replaced as a preventive measure.The system was tested and found to meet product specifications.Although the system met specs, (to help alleviate the customers concerns), a demo unit was installed for the facility to use in the interim.After multiple checks, the system was still found to have no problem.Therefore, the root cause of the reported event cannot be determined conclusively.The customer did not retain the pak lot information, therefore the device history records (dhr) traceable to the reported procedure pack could not be reviewed.A sample was not received to date for this complaint report; therefore, visual inspection or functional testing could not be conducted.Without a sample it cannot be determined if there were any physical anomalies that led to the customer's experience.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION 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: 9781456
• MDR Text Key: 186159497
• Report Number: 2028159-2020-00179
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• 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,Followup
• Report Date: 07/21/2020

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 Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 03/23/2020; 05/26/2020; 06/15/2020; 07/16/2020
• Supplement Dates FDA Received: 04/20/2020; 06/22/2020; 07/13/2020; 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION PROCEDURE PAK.