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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
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.A sample is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that during surgery, the tip was clogged when using ia.The surgery was completed with another product.There's no patient harm.
Additional Manufacturer Narrative
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 product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, a tip was returned for testing on this investigation.The tip was received for testing.A visual assessment of the returned sample found the port was clogged with foreign material.However, how or when the foreign material clogged the port remains inconclusive.The root cause of the reported event is attributed to foreign material.However, how or when the foreign material clogged the port remains 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).
Additional Manufacturer Narrative
Additional information was provided in section h.11.The customer reported was clogged.The reported event occurred during surgery.Patient impact was not reported.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 product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, the i/a tip was product returned for testing on this investigation.The irrigation and aspiration tip was received for testing.A visual assessment of the returned sample found the port was clogged with foreign material.Refer to the attached investigation log and photo.The was examined for foreign material testing.The collected debris was isolated and microscopically analyzed and found to contain one particle.The analysis of the clear fiber found the best match to be polydimethylsiloxane (silicone rubber).However, the exact origin of the particle remains inconclusive.However, how or when the foreign material clogged the port remains inconclusive.The root cause of the reported event is attributed to foreign material.However, how or when the foreign material clogged the port remains 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: 18815115
• Report Number: 2028159-2024-00317
• Device Sequence Number: 12839047
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 10/09/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 06/03/2024; 11/04/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION VISION SYSTEM.
• Patient Sex: Unknown