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

Catalog Number	8065771540
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One opened safety side port knife, in a bag was received for the report of blade broke off.Sample was visually inspected and found to be nonconforming, blade tip was observed to be broken off.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The photos attached to the parent file were reviewed by the manufacturing site.Photos show a safety knife with tip broken off.Reported issue confirmed from photos.The returned sample is visually non-conforming with the tip of the knife broken off.The root cause of the broken blade defect is manufacturing related issue.A nonconformance investigation was completed to investigate the 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 broken tip exhibited on the returned opened sample, is removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that an ophthalmic cutting blade broke off before use.Procedure details and patient impact were not reported.

• Brand Name: CLEARCUT S 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: 20810887
• Report Number: 2523835-2024-02393
• Device Sequence Number: 9935234
• Product Code: HNN
• UDI-Device Identifier: 00380657715404
• UDI-Public: 00380657715404
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K110166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/29/2024

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: 8065771540
• Device Lot Number: 16DDPR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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
• Patient Sex: Unknown