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	Insufficient Information (4580)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during cataract surgery an ophthalmic handpiece exhibited no ultrasound during the surgery in the quadrant mode.Information regarding patient impact was not reported.
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).
Additional Manufacturer Narrative
Corrected information was provided in sections: b2 and h11.The initial decision to report was incorrect resulting in the initial report being submitted in error.This event (no handpiece ultrasound during the operation in the quadrants program) is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.Phaco poor is not to be considered a reportable malfunction because a serious injury has not occurred and it is not likely that a recurrence would result in serious injury.It will be an inconvenience to the user, but due to the lower power input into the eye, patient risk will not be increased.No further reports will be submitted under mfg report num (b)(4).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: 21408160
• Report Number: 2028159-2025-00239
• Device Sequence Number: 15532915
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: (01)00380657504695(17)270626(11)170626(10)NA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/02/2025
• Date Device Manufactured: 06/26/2017
• 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