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

Catalog Number 8065753041

Device Problems Pressure Problem (3012); Unexpected Shutdown (4019)

Patient Problems Hemorrhage/Bleeding (1888); Vitreous Detachment (2445); Intraocular Pressure Decreased (4468); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/05/2023

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 physician reported that during a combined cataract vitrectomy surgery an ophthalmic system during fluid-air exchange(fax mode) the laser failed.Upon applying photocoagulation laser the system turned off completely leading to unstable pressure.The surgery could not continue and patient eye lost pressure.The system was restarted again but issue persisted.The wound was closed and patient was taken to another facility.Additional information has been requested.Additional information received indicated that after calibration upon resuming of the surgery choroidal detachment was observed.Intraocular instruments were removed, the vitreous cavity was filled with heavy liquid and air, caps were placed in trocars.The system was switched off six times.Three trocars were removed and mixed antibiotic and patch were placed.

Manufacturer Narrative

The company representative did not confirm nor replicate the reported event.The system was tested and found to meet product specifications.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 have no problem.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: 16425414
• MDR Text Key: 310041852
• Report Number: 2028159-2023-00236
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657530410
• UDI-Public: 00380657530410
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753041
• Device Lot Number: 14D8HU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK; STELLARIS PC ELITE EQUIPMENT
• Patient Outcome(s): Other; Required Intervention