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

Catalog Number 8065752914

Device Problems Excess Flow or Over-Infusion (1311); Overheating of Device (1437); No Flow (2991)

Patient Problems Corneal Edema (1791); Inflammation (1932); Intraocular Pressure Increased (1937); Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/13/2021

Event Type  Injury  

Event Description

A physician reported that during a cataract extraction procedure of a hyper mature lens, the phacoemulsification (phaco) handpiece (hp) overheats, unstable intraocular pressure (iop) and has a surge.The patient has experienced a flattened anterior chamber and a corneal burn at the incision site.The customer has tried to exchange the tip, ¿cap¿, cassette and adjusted the lens extraction technique with no resolution to the issue.The phaco hp was exchange which did resolve the issue.The case was completed.During the post-operative exam the patient was noted to have corneal inflammation for which medication therapy was required.This is one of three reports from this facility and represents the first patient.

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

Corrected information has been provided in h.6.Code 1941 has been updated to 1791.Code 1937 has been removed.Code 2991 has been updated to 1311.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The phaco handpiece was received and a visual assessment of the returned sample revealed no obvious nonconformities.A flow rate test was performed on the irrigation and aspiration lines of the phaco handpiece and met product specifications.The phaco handpiece was connected to a calibrated ophthalmic system.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.During the burn-in test, the temperature of the phaco handpiece was measured and was found to be within specifications.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the phaco handpiece to meet product specifications.A phaco handpiece 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.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.The phaco handpiece was found to meet specifications; therefore, the root cause of the reported event of high temperature and an infusion issue are 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, ACTIVE SENTRY 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: 12777977
• MDR Text Key: 280508783
• Report Number: 2028159-2021-01316
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: 00380657529148
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: 13M8K1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 01/14/2022
• Supplement Dates FDA Received: 11/09/2021; 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female