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

Model Number TABLETOP-JAPAN

Device Problems Computer Operating System Problem (2898); Failure to Shut Off (2939)

Patient Problems Visual Impairment (2138); Clouding, Central Corneal (2228)

Event Date 01/21/2020

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.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during a surgical procedure the screen became blue and the device did not work.Stand-by and power button were turned off but the screen remained blue and the power did not turn off.The procedure was aborted and schedule for completion on (b)(6) 2020.Additional information has been received stating the procedure was a combo cataract/retina surgery.The completion of surgery was on (b)(6) 2020.Clouding of the cornea with decreased visibility was noted postoperatively.The surgeon feels this was because of the discontinuation of the original surgery and the need for a 2nd surgery to be performed.

Manufacturer Narrative

Additional information is provided in d.10., g.1., g.2., h.3., h.6.And h.10.The blue display screen is a recoverable fault screen that includes recovery instructions: a problem has been detected and windows has been shut down to prevent damage to your computer.If this is the first time you have seen this stop error screen, restart your computer.If this screen appears again, follow these steps: check to make sure any new hardware or software is installed.If this is a new installation, ask your hardware or software manufacturer for any windows updates you might need.If problems continue, disable or remove any newly installed hardware or software.Disable bios memory options such as caching or shadowing.If you need to use safe mode to remove or disable components, restart your computer, press f8 to select advanced startup options, and then select safe mode.Contact your system administrator or technical support group for further assistance.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 company service representative examined the system and was able to replicate the illuminator issue.The illuminator electrode tube was replaced to resolve the issue.The company service representative was unable to replicate the reported events of the system screen turning blue and the system power not turning off.As a preventive measure, the supervisor module printed circuit board (pcb) and the host module were replaced.The supervisor module printed circuit board (pcb), the host module were received, and a visual assessment of the returned samples showed no obvious nonconformities.Further evaluation found the system to meet relevant specifications, including a 12-hour burn-in.The reported event could not be replicated.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The supervisor module printed circuit board (pcb) and the host module were 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: 9689704
• MDR Text Key: 178561830
• Report Number: 2028159-2020-00076
• 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: 04/16/2020

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-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 04/15/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR