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

Model Number TABLETOP

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/27/2020

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 customer reported that during a pars plan vitrectomy, removal of three piece intraocular lens implant (iol), and placement of an anterior chamber iol procedure, in the right eye, the flow of irrigation did not increase and as a result, the eye became soft and hemorrhaged.Additional information was received reporting the infusion line was primed outside of the eye, inserted into a trocar and visualized in the vitreous cavity in standard fashion.While performing the vitrectomy, the eye became hypotonus and it was apparent the infusion line was not working.Attempts were made to increase the intraocular pressure including raising the infusion cannula and injection of balanced salt solution manually through the trocar, however, in the process, the patient developed a moderate choroidal hemorrhage inferotemporally and superiorly, and a small choroidal hemorrhage superiorly.At this point, the vitrectomy was carefully completed without significant expansion of the choroidal hemorrhages as there was minimal vitreous remaining, and the wounds were closed.Postoperative visit one, the visual acuity was hand motion, which the doctor stated was to be expected as the patient was only count fingers pre-operatively.The patient is reported as stable and the prognosis is good at this point.The intraocular pressure was left at 35 to stabilize the eye.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.The company service representative examined the system and was not able to confirm or replicate the reported event of poor infusion.Unrelated to the reported events, the company service representative replaced the central processing unit (cpu) battery and the l5 solenoid.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 in relation to the reported events; 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: 10837659
• MDR Text Key: 216180384
• Report Number: 2028159-2020-00971
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR