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

Catalog Number	8065772265
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during a cataract surgery with intra ocular lens (iol) implant, ophthalmic knives were found to be blunt.The surgery was completed by backup knife.There was no patient harm.
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).H10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information is provided in section d.4, h.4.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Based on the information received following the submission of the initial report, the reported event is dissatisfied with the knife, not the blunt knife as originally stated.The information will be submitted under the file id# 2523835-2025-00142 and no further reports be submitted under the file id# 2523835-2025-00142.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: 21421956
• Report Number: 2523835-2025-00142
• Device Sequence Number: 20730812
• Product Code: HNN
• UDI-Device Identifier: 00380657722655
• UDI-Public: (01)00380657722655(17)280630(11)230712(10)15X5CF
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K110166
• 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,Followup
• Report Date (Section B): 04/01/2025

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: 8065772265
• Device Lot Number: 15X5CF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 02/21/2025; 03/03/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 02/27/2025; 04/01/2025
• Date Device Manufactured: 07/12/2023
• 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 Sex: Unknown