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

Model Number ASKU

Device Problem Increase in Suction (1604)

Patient Problem Hemorrhage/Bleeding (1888)

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 customer reported that the aspiration was overpowering the infusion during two surgical cases.Both patients experienced choroidal hemorrhages.

Manufacturer Narrative

Intraocular surgery has always been recognized to induce substantial intra-ocular pressure (iop) fluctuations, this is true for both anterior (i.E.Cataract surgery) and posterior segment (i.E.Vitrectomy) surgeries.Acute ocular hypotony is common during many intraocular surgeries.Intra-operatively, maintenance of eye pressure is a balance between infusion (irrigation) and extrusion (aspiration) with both parameters actively controlled by the surgeon and with the advent of iop control features, supported by vitrectomy/phaco machines.As stated in the operators manual: ¿the closed loop system that adjusts iop cannot replace the standard of care in judging iop intraoperatively.The surgeon must continue the common practice of informally judging the following: finger palpation on the globe, tactile feedback of the surgical instruments, retinal vessel perfusion/pulsations, and presence of corneal edema.If the surgeon believes the iop is not responding to the system settings and is dangerously high, the surgeon can do one or more of the following as they deem appropriate in this situation (with care to avoid sudden hypotony): close the infusion stopcock, pinch the infusion line, remove the infusion line.¿ the operator¿s manual includes the warnings: good clinical practice dictates the testing for adequate irrigation, aspiration flow, and operation as applicable for each handpiece prior to entering the eye.Visually confirm that adequate infusion flow is occurring prior to attachment of the infusion cannula to the eye.Warnings and cautions - pressurized infusion/irrigation solutions in bags: when using the s system in a pressurized infusion/irrigation mode, or with iop control feature enabled, users need to take precautions to not use bss irrigating solution or other infusion/irrigation mediums from pliable, collapsible containers (i.E.Bags).The system, when used in these pressurized modes, forces pressure into the infusion/irrigation container in order to force the solution out of the container and into the cassette.The pressure employed by the system may cause some infusion/irrigation bags to rupture and cause disruption of the surgical procedures.Only approved glass containers and bags should be used with the system when employing modalities of pressurized infusion/irrigation.The customer did not request service for the system.The system serial number was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.With no additional, related information provided, the customer reported event was not able to be confirmed.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: 9808688
• MDR Text Key: 182697281
• Report Number: 2028159-2020-00218
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other