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

Catalog Number	8065750469
Medical Device Problem Codes	No Device Output (1435); Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Corneal Clouding/Hazing (1878); Visual Disturbances (2140); Eye Burn (2523)
Date of Event	05/23/2025
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 healthcare professional reported that the cataract surgery (with intra ocular lens implantation) was performed in the right eye of the patient under locoregional anesthesia with intravenous and disinfection of conjunctival cul-de-sacs with povidone-iodine.A blepharostat instrument was used for corneal pre incision and 1.8 millimeter tunneled corneal incision was done to perform capsulorhexis under viscoelastic product.Then a lateral counter incision was done with the aid of non adrenaline local anesthetic agent in the anterior chamber to do hydro dissection and aspiration of the viscoelastic and phacoemulsification of the nucleus with reduced irrigation pressure.It was at that time, there was a appearance of a whitish cloud indicating occlusion of the phaco emulsification tip of the handpiece.The sculpting mode was put on hold and there was a thermal rigidification of the corneal edges.The handpiece was re-primed to continue the phaco emulsification with removal of masses and capsular polishing followed by implantation into the capsular bag under viscoelastic product.Corneal sutures were used in the corneal burn.The patient was then put on antibiotic injection with injection of filtered air bubble and intravenous cortico-steroid under conjunctiva followed by a check for water tightness and surgery was concluded with a dressing.Patient has been monitored by the surgeon, however, current patient condition was unknown.This report pertains to phaco emulsification handpiece involved in reported events.
Additional Manufacturer Narrative
Additional information is provided in sections a.1, a.2, a.3.A, h.6 and h.11.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.There was no product returned on this investigation.Based on the information obtained, the root cause of the reported event is inconclusive.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.Based on the information obtained, 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.
Additional Manufacturer Narrative
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.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.The 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 nonconformity.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 alcon 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.11 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: INFINITI 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: 22402808
• Report Number: 2028159-2025-00973
• Device Sequence Number: 13184899
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: (01)00380657504695(17)340619(11)240621(10)16WKJM
• Combination Product (Y/N): N
• Initial Reporter Country: MB
• PMA/510(K) Number: K112425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065750469
• Device Lot Number: 16WKJM
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 09/05/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 08/14/2025; 09/29/2025
• 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: INFINITI SURGICAL PROCEDURE PAK; LIDOCAINE; VISCOELASTIC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female