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

Model Number TABLETOP

Device Problem Pressure Problem (3012)

Patient Problems Hemorrhage/Bleeding (1888); Retinal Tear (2050); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/29/2021

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 nurse reported that a patient experienced choroidal hemorrhage and a sub retinal tear over the macula.When the surgeon pressed the infusion button an error message of infusion chamber overflow was displayed.Additional information received indicated that during a combination cataract/vitrectomy surgery, intraocular pressure (iop) indication disappeared off the screen.At the end of that procedure, the infusion was not working after he took infusion from one port to another port.The system displayed a message fluidics infusion chamber overflow.A posterior surgeon had removed patient lens fragments, and anterior surgeon performed secondary lens implantation.After an iol implantation, the surgeon noticed a choroidal hemorrhage and a sub retinal split between the optic nerve and the macula.The surgeon repaired the choroidal hemorrhage and lasered the back of the eye and stated that the macula is fine.Additional information has been requested.Additional information received confirmed that the patient was recovering.

Manufacturer Narrative

The system was examined.And the reported event was not replicated.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 will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 12358142
• MDR Text Key: 267812734
• Report Number: 2028159-2021-00934
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657511501
• UDI-Public: 00380657511501
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR