MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLEARCUT S INTREPID INCISIONAL INSTRUMENTS (WITH SHARPS INJURY PROTECTION); KNIFE, OPHTHALMIC

Catalog Number	8065772245
Medical Device Problem Codes	Material Separation (1562); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during cataract surgery, at the moment of the main corneal incision, the knife broke off and remained stuck in the cornea, detached from the sleeve.The surgeon removed the knife and changed scalpels.Patient impact have not been provided.Additional information has been requested, none has been received till date.
Event or Problem Description
Additional information received indicates that the surgery was completed on the same day and there was no patient harm.
Additional Manufacturer Narrative
Additional information is provided in section b.5 and h.6.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.One opened knife were received for the report of knife broke and remained stuck in the cornea.Sample was visually inspected and found to be nonconforming with blade broken off at the bend area of the blade.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The exact root cause could not be determined from the investigation performed.The returned sample is visually non-conforming with blade broken off at the bent area, therefore a broken knife reported by the customer was confirmed; how and when the knife became damaged could not be determined.; however a manufacturing related root cause could not be ruled out.An investigation has been completed to investigate issue with blade broken off.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Any nonconformance, such as the damaged blade exhibited on the returned opened sample is removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLEARCUT S INTREPID INCISIONAL INSTRUMENTS (WITH SHARPS INJURY PROTECTION)
• Common Device Name: KNIFE, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21712052
• Report Number: 2523835-2025-00392
• Device Sequence Number: 13294599
• Product Code: HNN
• UDI-Device Identifier: 00380657722457
• UDI-Public: (01)00380657722457(17)290131(11)240222(10)16KCD3
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2025

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: 8065772245
• Device Lot Number: 16KCD3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 03/28/2025; 06/16/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/16/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Age: 77 YR
• Patient Sex: Male