MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER UNITY PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number	8065000315
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that an ophthalmic handpiece was heated due to sterilization.The handpiece also exhibited system messages.The procedure details was not reported.No patient impact 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 provided in sections b.2 and h.11.The initial decision to report was incorrect resulting in the initial report being submitted in error.The event ¿temperature high was due to sterilization but not from the use¿.Hence this report of handpiece warm does not meet criteria for reporting based on applicable medical device regulations.No further reports will be scheduled under mfg report num: 2028159-2024-01467.The manufacturer internal reference number is: (b)(4).

• Brand Name: UNITY PHACO 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: 20308978
• Report Number: 2028159-2024-01467
• Device Sequence Number: 8759321
• Product Code: HQC
• UDI-Device Identifier: 00380650003157
• UDI-Public: 00380650003157
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 8065000315
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 10/05/2023
• 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: UNITY VCS CONSOLE
• Patient Sex: Unknown