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

Model Number TABLETOP

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Collapse (2416)

Event Date 12/30/2019

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 customer reported that during two separate procedures, the system was not maintaining the intraocular pressure.As a result, the eyes did not have the necessary tone causing the anterior chamber to collapse.The infusion was increased to 60mmhg.The surgical time was increased, however, the case were completed without patient harm.The customer indicated when loading and testing the device, the cassette and tubing were assembled correctly, and there were no sagging tubes (tubing) during the operation.The patient's eye level on the device was set correctly.

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.Hypotony (<5mmhg) is in fact fairly common in eye surgery that most eye surgeons anticipate this to occur during surgery.Surgeons have been trained to recognize and mitigate this by adjustment of the previously mentioned parameters be it manually or through the machine to adapt to what is being performed during surgery.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.The system was examined.The company representative did not indicate finding any issues that would be associated with the reported event.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event 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: 9612406
• MDR Text Key: 181630452
• Report Number: 2028159-2020-00030
• 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
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1