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

Catalog Number 8065753041

Device Problems Display or Visual Feedback Problem (1184); Electrical Power Problem (2925); Appropriate Term/Code Not Available (3191); Unexpected Shutdown (4019)

Patient Problems Retinal Detachment (2047); Retinal Tear (2050); Unspecified Eye / Vision Problem (4471)

Event Date 08/25/2022

Event Type  Injury  

Event Description

A physician reported that an ophthalmic console turned off and a black screen and lightning sign appeared during surgery.Patient eye was detached because of the liquid coming into the eye from the device that connected to the eye.The surgery was completed with the same console from the beginning.

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

Additional information received from physician indicated that the due to the electrical voltage drop, the retina was detached with a giant tear then the surgeon sedated the detached retina and lasered the device.The surgeon performed a liquid air exchange due to the power outage; the eye lobe activates its battery to protect its continuity and sends the infusion to the eye, and the eye is detached from the opposite side of the infusion inlet due to the refilling of pressurized fluid.The patient vision was impaired.Microscope surgery images were examined it was seen that that part was not in the camera recording, that is, the microscope was also affected by the interruption and did not record that part, and the problem was not caused by the device.Surgeon suspected that the ophthalmic console.The final condition of the patient was not certain because the patient left the country.

Manufacturer Narrative

Additional information is provided in b.5, d.4., and h.6.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The company service representative examined the system and was unable to confirm or replicate the reported event.The system was then tested and met all product specifications.A system non-conformance-based review of the batch/lot/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 lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/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: 15409931
• MDR Text Key: 299756476
• Report Number: 2028159-2022-01320
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657530410
• UDI-Public: 00380657530410
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2022

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
• Device Lot Number: 1412N1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 09/14/2022; 11/28/2022
• Supplement Dates FDA Received: 10/06/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other
• Patient Age: 10 YR