MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number 8065752914

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Decompensation (1790); Corneal Edema (1791); Loss of Vision (2139); Visual Disturbances (2140)

Event Type  Injury  

Event Description

A physician reported that an ophthalmic operating console and handpiece was used for the cataract surgery.Post to the cataract surgery the patients experienced the events corneal edema which results in the bad visual outcome.The corneal edema of these patients were being monitored for the past three weeks but still no significant improvement.Additional information has been requested and none received till date.This report pertains to phacoemulsification handpiece involved in this reported event.

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 has been received indicating that two patients experienced the events impending corneal decompensation with loss of vision.The current patient condition was not recovered with the existing conditions.

Manufacturer Narrative

The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, there was no product returned for testing on this investigation.Based on the information obtained, the root cause of the reported events is inconclusive.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.Potentially relevant complaints were found and reviewed as part of this investigation.Based on the information obtained, the root cause of the reported events 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).

Event Description

A physician reported that a patient with a grade three cataract underwent cataract surgery with monofocal lens implantation using an ophthalmic operating console.At one-week post-op, the patient exhibited corneal edema and corneal decompensation in the left eye, for which the patient was treated with corticosteroids and sodium chloride eye drops.The physician saw the patient at three months follow up from procedure and it was observed that the patient had not yet recovered.An additional follow up appointment was scheduled with the physician; however, the patient did not return for the follow up.The status of the patient is unknown.No additional information is available currently.This complaint is pertaining the ten of thirty-five reports received from the initial reporter.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE
• 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: 18147153
• MDR Text Key: 328225044
• Report Number: 2028159-2023-01570
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: 00380657529148
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: 15PJH6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 02/07/2024
• Supplement Dates FDA Received: 01/05/2024; 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM (ACTIVE SENTRY); CENTURION VISION SYSTEM (ACTIVE SENTRY)
• Patient Outcome(s): Other; Required Intervention