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); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that during surgery, the ophthalmic handpiece became occluded and had poor irrigation, and the patient experienced a corneal burn and underwent corneal suture and also received corticoids as a local treatment.The current patient condition was resolved.This complaint is pertaining the second of three reports received from the initial reporter.
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
Corrected information provided in d.1 additional information was 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 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 with the same event code.The hp was received for testing on this investigation.A visual assessment of the returned sample revealed no obvious non-conformity.The handpiece was connected to a calibrated resistance breakout box, where the resistance and dissipation were found to be within specification.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to meet 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 not meet specifications.The root cause of the reported ¿poor irrigation and occlusion¿ was found to meet specifications.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: 22806276
• Report Number: 2028159-2025-01211
• Device Sequence Number: 7836916
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: (01)00380657504695(17)340619(11)240621(10)16WKJP
• Combination Product (Y/N): N
• Initial Reporter Country: MB
• PMA/510(K) Number: K121555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: 16WKJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female