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

Catalog Number	8065750469
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Scar (1793); Inflammation (1932); Uveitis (2122); Visual Disturbances (2140); Eye Burn (2523); Fluid Discharge (2686)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A customer reported that during vitrectomy surgery system/handpiece/tip malfunctioned due to which patient experienced corneal burn it leads to vision impact, wound was sutured in left eye.Patient current condition was not reported.New information has been received indicating patient left eye has wound leakage and many striae are present of the cornea causing astigmatism and other aberrations.Currently vision is counting fingers vision.He is also having uveitis, intraocular inflammation.Current condition was not known.
Additional Manufacturer Narrative
Additional information provided in section d.1 and d.4.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 has been 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.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.All relevant complaints found, were (reviewed as part of this investigation.A hp was received for testing.A visual assessment of the returned sample revealed no obvious non-conformities.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, 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CENTURION SILVER 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: 23074615
• Report Number: 2028159-2025-01373
• Device Sequence Number: 4645221
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: (01)00380657504695(17)300906(11)200908(10)13MV4V
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065750469
• Device Lot Number: 13MV4V
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 01/16/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/28/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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: CONSTELLATION VISION SYSTEM; CUSTOM-PAK SURGICAL PROCEDURE PACK
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown