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

Catalog Number 8065752914

Device Problem Complete Blockage (1094)

Patient Problems Fibrosis (3167); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 03/08/2023

Event Type  Injury  

Event Description

A health care professional reported that, a patient who underwent cataract surgery using an ophthalmic handpiece developed postoperative tass (toxic anterior segment syndrome) and fibrin was noted in the anterior chamber of the eye.The patient was treated with steroids, nsaid¿s (non-steroidal anti-inflammatory drugs) and antibiotics hourly while awake, and the symptoms resolved by the second day without any reported signs or symptoms of pain.The handpiece testing by third-party resulted in occlusions.This is the eight of eight-product report for this patient from the reporting facility related to the same 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.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, the phacoemulsification handpiece (hp) was returned for testing on this investigation.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 review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The handpiece was received for testing on this investigation.Noting, it could only be tested for functionality and not for any bioburdens as they were autoclaved once delivered.A visual assessment of the returned sample revealed no obvious non-conformity.The handpiece was connected to a calibrated resistance breakout test box, where the connection between the input and output impedance of the sensor was found to be within specifications.The resistance and dissipation between low electrode and high electrode were also tested for and found to both be 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.During the burn-in test, the temperature of the hp was measured and was found to be within specifications.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 specifications.The irrigation and aspiration lines of the handpiece were flushed for particulates testing.The collected debris was isolated and microscopically analyzed and found to contain numerous clear fibers up to 750m in length and a high number of reflective particles up to 120m in length on the filter.The analysis of the clear fibers found the best match to be nylon.The analysis of the metallic particles identified elements including aluminum (al), titanium (ti), and vanadium (v).The presence of these elements along with the visual characteristics suggests the particles are likely from a titanium alloy.However, the exact origin of the fibers and metallic particles remains inconclusive.Based on the information obtained, the root cause is inconclusive and there is no indication that the handpiece manufacturing process contributed to the reported patient impact.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: 16741397
• MDR Text Key: 313293533
• Report Number: 2028159-2023-00540
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: 00380657529148
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: 127A7H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION VS.; LENSTEC SOFTEC 1,; MOXIFLOXACIN,; NEPAFENAC,; PREDNISOLONE,
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female