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

Model Number TABLETOP-JAPAN

Device Problem Unstable (1667)

Patient Problem Intraocular Pressure, Delayed, Uncontrolled (1936)

Event Date 02/26/2016

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 that during a cataract/vitrectomy procedure, the patient's intraocular pressure was unstable.The procedure was completed without patient harm.Additional information has been requested.

Manufacturer Narrative

A company clinical analyst reviewed this case and stated the following: ¿the customer reported an unstable intraocular pressure (iop) occurred during the case.There was nothing abnormal in functional check, so customer suspected the pak to have contributed to the reported event.Two used products were returned.The surgery was completed with continued usage of the reported product.Additional, related information was requested but was not obtained.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.There are numerous times during cataract surgery (incidence=0.06%-0.16%1,2), glaucoma filtration surgery (0.15%2), vitrectomy (0.41%2), penetrating keratoplasty (0.56%2), k-pro surgery, dsek, iofb removal and trauma repair when there is no infusion and the eye is at atmospheric pressure.Pars plana vitrectomy (ppv) differs from other intraocular surgical procedures in that the prolonged acute hypotony is not a predominant feature.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 system operators manual notes the system is a closed loop system that adjusts iop.The iop control cannot replace the standard of care in judging iop intraoperatively.The system was examined and the reported event was not replicated.However, the company representative noted that the three-way stopcock attachment was loose.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on august 26, 2011.Based on qa assessment, the product met specifications at the time of release.The first (consumable pak) lot complaint history was reviewed.This is the fifth complaint for the finish goods lot.However, the second for this issue.The device history record (dhr) shows the product was released per specifications.The returned sample was visually inspected and no obvious defects were found.The cassette's filters were observed to be saturated with balanced salt solution (bss) in returned condition and had to be dried to continue functional testing.It is possible for the cassette to not function per specification when the cassette is saturated with fluid on the infusion filters of the cassette.A console representing the current software version was used to test the sample.The ball in the check valve of the drip chamber moved freely per specification.The sample could prime and pass iop calibration successfully.No anomalies were observed during priming.The infusion pressure, irrigation, and aspiration rate were all measured at multiple set points throughout the console range and met specifications.Toggling the infusion and the fluid/air exchange (f/ax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubble in various settings in all sub modes.No message code appeared on the screen.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.The root cause of the customer's complaint could not be established.The returned sample met specifications.The second (consumable pak) complaint history was reviewed, this is the third complaint for the finish goods lot; however, the first for this issue.The device history record (dhr) shows the product was released per specifications.The returned sample was visually inspected and the drain bag was not returned.Additionally, the cassette filters were observed to be saturated with balanced salt solution (bss), in returned condition.It is possible for the cassette to not function per specification when the cassette is saturated with fluid on the infusion filters of the cassette.A console representing the current software version was used to test the sample.The ball in the check valve of the drip chamber moved freely per specification.The sample could prime and pass iop calibration successfully.No anomalies were observed during priming.The infusion pressure, irrigation, and aspiration rate were all measured at multiple set points throughout the console range and met specifications.Toggling the infusion and the fluid/air exchange (f/ax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubble in various settings in all sub modes.No message code appeared on the screen.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.The root cause of the customer's complaint could not be established.The returned sample met specifications.The system was verified to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: 2016-15770.

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5513562
• MDR Text Key: 41041351
• Report Number: 2028159-2016-01201
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

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-JAPAN
• Device Catalogue Number: 8065751817
• Other Device ID Number: 3.00.61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2016
• Initial Date FDA Received: 03/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other