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

Catalog Number	8065750469
Medical Device Problem Codes	Obstruction of Flow (2423); Excessive Heating (4030)
Health Effect - Clinical Codes	Corneal Clouding/Hazing (1878); Eye Burn (2523); Intraocular Pressure Decreased (4468)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that during cataract surgery, an ophthalmic handpiece was hot with white smoke emanated from the tip.The patient has experienced corneal wound burn and also cornea opacified with a small gap during the procedure in the left eye.The surgery was completed on the same day with another handpiece.The patient condition is improving.
Additional 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information provided in sections d9, h3, h6 and h11.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.A phaco 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.There were no similar complaints reported for the product¿s serial number (under investigation), with the same event code.The handpiece was received for testing.A visual assessment of the returned sample revealed a dented irrigation line.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 handpiece was measured and was found to be within specifications.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to meet manufacturer 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.Therefore, based upon the information obtained, the root cause of the reported event(s) remains inconclusive.The potential causes of the reported ¿corneal burn, the handpiece becoming too hot, corneal opacity, hearing the occlusion tone, and chamber shallowing¿ can be attributed to surgical mitigations or surgical factors.By proactively implementing preventive strategies to optimize surgical outcomes, surgeons will prioritize patient safety during msics procedures.The handpiece was found to meet specifications.Therefore, based upon the information obtained, the root cause of the reported event(s) remains 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, OZIL TORSIONAL HANDPIECE
• Common Device Name: 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: 23704031
• Report Number: 2028159-2025-01787
• Device Sequence Number: 21500286
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: (01)00380657504695(17)300919(11)200921(10)13N1NV
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065750469
• Device Lot Number: 13N1NV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION SURGICAL PROCEDURE PAK.; CENTURION VISION SYSTEM (ACTIVE SENTRY).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female