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	Insufficient Information (4580)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A government agency reported that after the completion of the cataract surgery the phacoemulsification irrigation and aspiration handpiece accidentally fell on the ground and the needle had broken and could not be used further.
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 needle had broken is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.No further reports will be submitted under mfg report num 2028159-2024-01365.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: 20210789
• Report Number: 2028159-2024-01365
• Device Sequence Number: 15397181
• Product Code: HQC
• UDI-Device Identifier: 00380657510139
• UDI-Public: 00380657510139
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/04/2024

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 12/04/2024
• 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 Age: 56 YR
• Patient Sex: Male