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 Edema (1791); Blurred Vision (2137); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 healthcare professional reported that after using ophthalmic handpiece and console in a cataract surgeries patient experienced corneal edema with corneal opacity after two weeks post operation and it lead to loss of best corrected visual acuity.The patient's current conditions were improving slowly.

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 batch/lot/serial number was performed and did not reveal a contributing factor.A review for complaints reported against this lot/batch/serial number was performed.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).

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 with visual disturbance in the left eye, for which the patient was treated with corticosteroids 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.In the fourth month patient was fully recovered.This complaint is pertaining the first of two reports received from the initial reporter.

• 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: 18552626
• MDR Text Key: 333362679
• Report Number: 2028159-2024-00114
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 8065753057
• Device Lot Number: 15LMC1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 03/05/2024
• 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: ACCESSORY, ACTIVE SENTRY HANDPIECE
• Patient Outcome(s): Other; Required Intervention