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

Catalog Number 8065751761

Device Problems Complete Blockage (1094); Inability to Irrigate (1337)

Patient Problems Corneal Clouding/Hazing (1878); Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/08/2023

Event Type  Injury  

Event Description

A nurse reported that during a cataract surgery while using an ophthalmic phacoemulsification handpiece, a patient experienced corneal burn at the primary incision while in quad mode and sutures were placed, the handpiece was occluded with occlusion tone which caused by a lack of fluid to be delivered.The anterior chamber was collapsed during surgery and postoperatively the patient had astigmatism and white corneal opacity.Sutures will be in place for next two months and expecting patient recovery.

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).

Manufacturer Narrative

The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, this hp was returned for testing on this investigation.A non-conformance based review of the batch/lot/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 lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The hp was received for testing on this investigation.A visual assessment of the returned sample revealed no obvious non-conformities.When the handpiece was connected to a calibrated breakout test box, the resistance and dissipation between low electrode and high electrode were both within specifications.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to meet specifications.The returned sample was connected to a calibrated system.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet specification.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.The handpiece 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, ACCESSORY, OZIL TORSIONAL 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: 17255469
• MDR Text Key: 318370140
• Report Number: 2028159-2023-00948
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751761
• Device Lot Number: 151PTL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION SURGICAL PROCEDURE PAK.; CENTURION VISION SYSTEM.
• Patient Outcome(s): Other; Required Intervention