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

Catalog Number 8065753057

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

Patient Problems Corneal Decompensation (1790); Corneal Edema (1791)

Event Type  Injury  

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 right 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 twelve of thirty-five reports received from the initial reporter.

Manufacturer Narrative

This the 12th of 35 reports received from the initial reporter clarifying the events as previously reported under mfg.Report number (2028159-2023-01571, 20268159-2023-01572, 2028159-2024-00313, 2028159-2024-00314).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

The company representative was unable to 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 non-conformance based review of the serial number was performed and did not reveal a contributing factor.A review for complaints reported against this serial number was performed.Potentially relevant complaints were found and reviewed as part of this investigation.All complaints were opened for the same set of complaints against the system involved with corneal edema cases.The investigations for all system complaints will mirror each other as the servicing for the system was referenced.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: CENTURION VISION SYSTEM (ACTIVE SENTRY)
• 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: 18826442
• MDR Text Key: 336849733
• Report Number: 2028159-2024-00349
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657530571
• UDI-Public: 00380657530571
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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: 8065753057
• Device Lot Number: 15LMC1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION ACTIVE SENTRY HANDPIECE
• Patient Outcome(s): Other; Required Intervention