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

Catalog Number 8065751763

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

Patient Problems Hyphema (1911); Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

In a literature article, an investigator detailed a study aimed at comparing the postoperative inflammatory reaction following phacoemulsification using a handpiece in cataract patients with primary angle closure glaucoma (pacg) under low and conventional intraocular pressure (iop) settings.The study involved 74 eyes of 74 patients with cataract and pacg, all having axial lengths within the range of 20-22 mm.The eyes were divided into two groups based on the iop setting (30mmhg or 50mmhg) during the phacoemulsification handpiece usage.The assessment included grading of anterior chamber flare (acf), grading of anterior chamber cells (acc), and iop measurements, all compared between groups at 1 day, 1 week, and 2 weeks post-surgery.During the postoperative analysis, it was observed that some patients encountered complications such as anterior chamber bleeding, hyphemia, and choroidal leakage.However, all patients facing complications received either pharmacological or surgical interventions, leading to stabilized conditions.The findings of this study indicated that a lower iop setting during cataract surgery, using the phacoemulsification handpiece, can effectively reduce early postoperative inflammatory reactions in cataract patients with pacg.This report pertains to ophthalmic operating system 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."comparison of postoperative inflammatory reaction under different iop settings using centurion vision system with active sentry handpiece in pacg eyes." the manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in sections h.6.And h.10.Specific product identifiers (serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this serial number cannot be performed as the serial number is unknown.The serial is unknown.Therefore, a service history review cannot be performed.Based on the information obtained, the root cause of the reported event is inconclusive.Based on the information obtained, 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
• 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: 18524332
• MDR Text Key: 332974766
• Report Number: 2028159-2024-00089
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657517633
• UDI-Public: 00380657517633
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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: 8065751763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACTIVE SENTRY HANDPIECE
• Patient Outcome(s): Required Intervention; Other