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

Catalog Number	8065912001
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Six unopened 20g v-lance blades were returned for the report of deformed package.The samples were visually inspected and found to be non-conforming with package observed to be crushed/dented and distorted.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 returned non-conforming samples were received unopened.How and when the package became deformed cannot be determined from this evaluation; however, a manufacturing related issue could not be ruled out.All packages are 100% scanned by trained operators.Any non-conforming packages identified are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).
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 physician reported that before cataract surgery, an ophthalmic cutting knife packaging was different from usual.The procedure was completed with alternative product.No patient impact was reported.

• Brand Name: V-LANCE 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: 20889857
• Report Number: 2523835-2024-02430
• Device Sequence Number: 7716463
• Product Code: HNN
• UDI-Device Identifier: 00380659120015
• UDI-Public: (01)00380659120015(17)290131(11)240221(10)16K9FP(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 01/06/2025

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: 8065912001
• Device Lot Number: 16K9FP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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