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

Catalog Number 8065753008

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

Patient Problems Corneal Edema (1791); Blurred Vision (2137); Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/13/2024

Event Type  Injury  

Event Description

A customer reported that during a cataract surgery utilizing an ophthalmic system, phacoemulsification handpiece and phacoemulsification tip the male patients experienced corneal burn, severe decrease in visual acuity (va), and corneal edema with endothelial folds in right eye.The patients had preexisting conditions including optimal endothelial count and medium to low hardness of cataracts.The surgeon suspects that the corneal edema may be related to excessive parameters (90% torsional phaco) and the use of an incorrect balanced needle for medium-low hardness cataracts, potentially resulting in collapses.Additional treatment, including corticosteroids and anti-edema eye drops, was administered.All patients are currently in the post-operative recovery period.This complaint is pertaining the first of four reports received from the initial reporter.

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).

• Brand Name: CENTURION SILVER 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: 19113961
• MDR Text Key: 340226652
• Report Number: 2028159-2024-00553
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K121555
• 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
• Report Date: 04/16/2024

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: 8065753008
• Device Lot Number: 168YCD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/16/2024
• 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: CENTURION SURGICAL PROCEDURE PAK; OZIL TORSIONAL HANDPIECE; SMALL PART KIT
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male