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

Catalog Number 8065753041

Device Problem Inability to Irrigate (1337)

Patient Problems Hemorrhage/Bleeding (1888); Hyphema (1911); Intraocular Pressure Increased (1937); Visual Impairment (2138); Vitreous Hemorrhage (2143); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/07/2021

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 customer reported that during a surgery an ophthalmic operating console had no infusion in oil removal phase, which resulted in hypotony and suprachoroidal hemorrhage in a patient.Additional information has been requested.Additional information received indicated that the patient was scheduled for a silicon oil removal surgery.The patient had a stable eye with 20/40 vision prior the surgery.The infusion was stopped during oil removal phase about half way through the removal.The surgeon noticed the eye was soft and stopped aspirating with the oil removal cannula.The eye remained collapsed for at least 30 seconds and did not appear to be reinflating.The surgeon kept the infusion pressure up to 60 and still the eye remained soft, but slowly started to reform over the next 30 seconds.There were no error messages on the screen.Though it re-inflated, it remained soft despite the setting of 60.Through the pupil the surgeon could see choroidals forming, but slowly removed the remainder of the oil.The surgeon enter into the eye with light pipe and cutter and had a fairly large choroidal effusion nasally, extending to the disk.The infusion pressure high, removed the cannulas and closed the sclerotomies with suture.At the completion, the globe was slightly firm to palpation.The following day, the patient's vision was hand motions only.The intraocular pressure (iop) was 35.The patient had hyphema, vitreous hemorrhage and 360 degree hemorrhagic choroidals by ultrasound.The patient remained in hand motions with large hemorrhagic choroidals.Additional information received indicating the patient's current condition is unchanged.Additional information received indicating the surgeon completed the surgery and sutured the wounds at the end.The hypotony lasted for about a minute.The patient not yet recovered from the event.She continued to have pain, elevated intraocular pressure (iop).

Manufacturer Narrative

The company service representative examined the system and confirmed the reported event of an infusion issue.However, the company service representative was unable to replicate the issue while on-site.As a preventative measure, the system was replaced.The system was then tested and met all product specifications.The system was received, and a visual assessment of the returned sample revealed discoloration and balanced salt solution (bss) residue.The system was calibrated and turned on.No system message was generated after the boot up sequence.The system was tested per standard test procedure (stp) and the complaint was not replicated.The reported event of the patient experiencing suprachoroidal/vitreous hemorrhage, hyphema cannot be confirmed.A system 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.The root cause cannot be determined conclusively.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: 12575428
• MDR Text Key: 274696706
• Report Number: 2028159-2021-01147
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other