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

Model Number TABLETOP

Device Problems Decrease in Pressure (1490); Detachment of Device or Device Component (2907)

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

Event Date 02/25/2020

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.(b)(4).

Event Description

A healthcare professional reported an iop compensation issue with the system during a vitrectomy procedure.There was a decrease of the pressure.In response, the surgeon increased the intraocular pressure and decreased aspiration.The procedure was completed.The patient experienced a choroidal detachment.

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.

Manufacturer Narrative

The system was examined and the reported ¿iop issue¿ was replicated.The fluidics was replaced to resolve the issue.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 root cause of the iop issue can be attributed to the nonconforming fluidics.Based on the information obtained, the root cause of the reported patient impact cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Corrected and additional information has been provided in h.6 and h.10.The system was examined and the reported system message (sm) was confirmed (via event log review) but was not replicated.However, as a preventive measure the fluidics was replaced.The system was tested and found to meet product specifications.At some point, the surgeon asked for a demo unit to be brought in and used to alleviate reoccurrences.Additionally, the settings were then reset to default, as a preventive measure.The system was found to have no problem.Therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

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).

• 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: 9865822
• MDR Text Key: 184479825
• Report Number: 2028159-2020-00267
• 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
• Report Date: 08/25/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 05/26/2020; 06/15/2020; 08/06/2020
• Supplement Dates FDA Received: 06/22/2020; 07/13/2020; 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK; CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other