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

Catalog Number 8065753041

Device Problem Gas Output Problem (1266)

Patient Problems Loss of Vision (2139); Intraocular Pressure Decreased (4468)

Event Date 12/08/2022

Event Type  Injury  

Event Description

A customer reported that while using the auto gas feature it dispensed the gas which caused the patient's intraocular pressure to spike.Surgeon was informed that the machine was unable to dispense any gas other than the gas selected on the screen.Additional information received indicated that the procedure scheduled was vitrectomy with endo laser pan retinal photocoagulation, membrane peel scleral buckle replacement of the left eye as the patient had permanent vision loss in left eye.

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).

Manufacturer Narrative

Additional information is provided in section b.5 the manufacturer internal reference number is: (b)(4).

Event Description

Additional information received indicated that system message(sm) was displayed.

Manufacturer Narrative

The company representative was unable to confirm nor replicate the reported issue.The system was tested and was found to meet product specification.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The system was found to meet specifications.Therefore, the root cause of the reported event is inconclusive.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16112617
• MDR Text Key: 306802613
• Report Number: 2028159-2023-00027
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657530410
• UDI-Public: 00380657530410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753041
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PROCEDURE PAK, AUTO GAS FILL
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female