MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLEARCUT KNIVES; KNIFE, OPHTHALMIC

Catalog Number	8065982665
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2025
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 customer reported that the label on an ophthalmic cutting instrument box was incorrect.However, no procedure details or patient impact have been reported at this time.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report of wrong labeling; however, the attached customer photos confirm the reported issue of an incorrect product description on unit carton box label.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 photo review confirms that the reported issue of wrong labeling on the unit carton boxes.The customer report also states that the gtin number is different on the case and on the box; however, this is not a discrepancy.The global trade item number (gtin) is a unique product id number issued to each trade item including higher levels of packaging (unit, case, pallet, etc.).The leading number is different to identify the different levels of packaging (i.E.2, 1, 0) from the cases down to the product package.Based on the evaluation of the information received, the investigation concluded that the root cause of the reported event is manufacturing related due to a data entry error within the labeling software where the description field was not updated, resulting in an incorrect label stating 2.8mm instead of 2.6mm and was missed at label verification and downstream inspection.An acceptance quality limit (aql) sampling is performed to ensure that the product meets release acceptance criteria.Complaint data for all manufacturer products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLEARCUT KNIVES
• 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: 22467011
• Report Number: 2523835-2025-00745
• Device Sequence Number: 15477216
• Product Code: HNN
• UDI-Device Identifier: 00380659826658
• UDI-Public: (01)00380659826658(17)290930(11)241021(10)173Y0R
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• PMA/510(K) Number: EXEMPT
• 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): 10/06/2025

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: 8065982665
• Device Lot Number: 173Y0R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/06/2025
• Date Device Manufactured: 10/21/2024
• 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 Sex: Unknown