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

Catalog Number 8065752914

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

Patient Problems Corneal Edema (1791); Blurred Vision (2137); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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).

Event Description

A healthcare professional reported that after using ophthalmic handpiece and console in a cataract surgeries patient experienced corneal edema with corneal opacity after two weeks post operation and it lead to loss of best corrected visual acuity.The patient's current conditions were improving slowly.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that a patient with a grade three cataract underwent cataract surgery with monofocal lens implantation using an ophthalmic operating handpiece.At one-week post-op, the patient exhibited corneal edema with visual disturbance in the left eye, for which the patient was treated with corticosteroids eye drops.The physician saw the patient at three months follow up from procedure and it was observed that the patient had not yet recovered.In the fourth month patient was fully recovered.This complaint is pertaining the first of two reports received from the initial reporter.

Manufacturer Narrative

Additional information provided in sections d.9.H.3.H.6 and h.11.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, a handpiece (hp) was returned for 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.Quality summaries (qs¿s) were opened for the events that occurred with the demo and replacement systems, and at other dates with different patients.The investigations will mirror this investigation.The investigation logs for the handpiece are documented in the first qs opened.The hp was received for testing on this investigation.A visual assessment of the returned sample revealed no obvious non-conformities.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.When the handpiece was connected to a calibrated breakout test box, both the resistance and dissipation between low electrode and high electrode were found to be out of specifications.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to fail specifications.The handpiece channels were inspected with a borescope which revealed no obvious nonconformities.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 specifications.However, as the borescope test did not reveal any nonconformities, a second set of a visual and functional assessments were performed on the handpiece to confirm the prior results.A particulate test was performed in which no particles were found.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.When the handpiece was connected to a calibrated breakout test box, the resistance between low electrode and high electrode was found to be out of specifications.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to then meet specifications per product specifications.When 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 dtf for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet specifications.The nonconforming specifications related to resistance, dissipation, and flow are not related to the reported corneal edema.The customer reported event was not able to be confirmed.Based on the information obtained, the root cause of the reported events 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 18550735
• MDR Text Key: 333314457
• Report Number: 2028159-2024-00106
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: 00380657529148
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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: 8065752914
• Device Lot Number: 15PJH6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM (ACTIVE SENTRY)
• Patient Outcome(s): Required Intervention; Other