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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that when installing the irrigation aspiration tip, it was broken from the root.The surgery was performed and completed after replacing the product with another one.The procedure type is unknown.
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
Additional information is provided in sections d.9, h,3, h,6 and h.11.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, an irrigation/aspiration (i/a) tip was returned for testing on this investigation.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 lot is unknown.Therefore, a service history review cannot be performed.The i/a tip was received for testing on this investigation.A visual assessment of the returned sample revealed it to be broken at the shaft where the base was detached, confirming the reported event.However, although the reported event can be confirmed, how the tip became nonconforming could not be determined conclusively.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).

• 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: 18390630
• Report Number: 2028159-2023-01708
• Device Sequence Number: 16812587
• Product Code: HQC
• UDI-Device Identifier: 00380657510139
• UDI-Public: 00380657510139
• 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): 06/26/2024

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: 8065751012
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 12/25/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown