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

Model Number TABLETOP

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/04/2019

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 nurse reported the infusion pressure on the system was reading zero during a vitrectomy.The staff indicated the surgeon did not lose pressure in the eye.The surgery was completed.There was no patient harm.

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.The vision system operator¿s manual contains instructions for proper prime and setup.The graphical user interface also prompts the user through all of the steps required to prime and tune the phaco handpiece appropriately.The operators manual also states the following warning(s): adjusting aspiration rates or vacuum limits above the preset values, or lowering the iop or iv pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.Ensure that appropriate system parameters and system settings are selected prior to starting the procedure.Parameter and system settings include, but are not limited to, ultrasound mode, ultrasound power, vacuum, aspiration flow rate, bottle height, iop, etc.If stream of fluid is weak or absent while filling test chamber, good fluidics response will be jeopardized.Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.Ensure that the tubings are not occluded during any phase of operation.If the handpiece test chamber is collapsed after tuning, there is a potential of low irrigation flow through the handpiece and may result in a fluidic imbalance.This, in turn, may cause a shallowing or collapsing of the anterior chamber.Good clinical practice dictates testing for adequate irrigation, aspiration flow, reflux, and operation as applicable for each handpiece prior to entering eye.There is no evidence that the design or manufacturing of the system contributed to the reported event.The company service representative examined the system but was unable to replicate the reported event.The ar updated the system software as a prevention.Unrelated to the reported event, the xenon lamp was replaced as a prevention.The system was then tested and met all product specifications.The system 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: 8541923
• MDR Text Key: 142934763
• Report Number: 2028159-2019-00748
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• 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: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1