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 Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that during cataract surgery, the ophthalmic handpiece passed testing and tuning, but there were no ultrasounds output.The surgery was completed on the same day using a different handpiece.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in sections h.6., and h.11.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.Service history was reviewed for the system.No service record relevant to the complaint reported event was found.The sample has not been received by the manufacturing site; therefore, the customer reported event cannot be confirmed.Based on the information obtained, the root cause of the reported event is inconclusive.The root cause of the reported event is inconclusive.Therefore, no further actions will be pursued at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Receipt of complaint sample or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information received in the section of h.6., and h.11.The functional history of the returned handpiece was evaluated, where it was found to have been re-used greater than 400 times.Per its directions for use, ¿when the handpiece is used properly per this directions for use, 400 re-uses have been verified.¿ therefore, as the product was re-used beyond its verified life, additional evaluation is not required.As stated in the console operator¿s manual, the system is designed to perform self-checks to ensure proper functionality.If the system detects an issue that may compromise the integrity of the system¿s output, then the system is designed to produce a system message to alert the user and to disable the affected function, handpiece, or system until the issue has been resolved.This is meant to preclude use of a compromised function, handpiece, or system for surgery.It should be noted that there was no harm to the patient nor did the handpiece itself pose any potential harm to the patient.The root cause of the customer's complaint is likely related to re-use beyond the verified life of the handpiece as stated in the directions for use.No action will be taken for this occurrence, as the root cause of the customer complaint is likely related to customer re-use beyond the verified life of the handpiece as stated in the directions for use.Quality assurance will continue to monitor for evidence of adverse trending of reported events and take further action, as appropriate.At a minimum, this will include completing reviews of complaint event code levels on a monthly basis by the product team.The manufacturer internal reference number is: (b)(4).

• 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: 23628643
• Report Number: 2028159-2025-01724
• Device Sequence Number: 9381922
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: (01)00380657504695(17)300307(11)200309(10)13KAKP
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065750469
• Device Lot Number: 13KAKP
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 03/11/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/18/2026; 04/02/2026
• Date Device Manufactured: 03/09/2020
• 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
• Patient Sex: Unknown