MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INTREPID AUTOSERT IOL HANDPIECE, I/A TIP; APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED

Catalog Number	8065751012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	10/21/2024
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).
Event or Problem Description
A physician reported that during surgery, patient experienced posterior capsule rupture while removing cortex with the irrigation aspiration handpiece.It was noted that the suction port of the irrigation aspiration tip was damaged, likely due to a burr on the tip.Surgery was completed on the same day with an alternative tip and by changing the type of intraocular lens (iol) from a single-piece iol to a three-piece iol, which was scheduled for insertion.
Additional Manufacturer Narrative
Corrected information was provided in b.2 previously submitted outcome reportable malfunction has been removed.Additional information is provided in sections 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 equipment returned for testing.Based on the information obtained, the root cause of the reported event is inconclusive.Specific product identifiers (lot number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this lot number cannot be performed as the lot number is unknown.The system was found to have no problem.Therefore, 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).

• Brand Name: INTREPID AUTOSERT IOL HANDPIECE, I/A TIP
• Common Device Name: APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED
• 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: 20706617
• Report Number: 2028159-2024-01778
• Device Sequence Number: 18155482
• Product Code: HQC
• UDI-Device Identifier: 00380657510122
• UDI-Public: 00380657510122
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065751012
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown