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

Catalog Number	8065912001
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
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 physician reported that during surgery, an ophthalmic cutting knives did not cut like they did the previous times.The surgery was completed with alternative product.There was no patient impact.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.30 opened 20 ga v-lance knives with foam protectors in a bag were received for the report of knives didn't cut like they did the previous times.Samples 1-6, 8, 11-15, 18-20,22-25 and 27-30 were visually inspected and found to be nonconforming with damaged cutting edge and/or bent tip.Functional penetration testing could not be performed due to the damage of the samples.Samples 7, 9, 10, 16, 17, 21, 26 were visually inspected and all were found to be conforming.Functional penetration testing was performed and samples were found to be conforming.A review of the device history record traceable to the reported lot numbers, 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 damage to the returned samples 1-6,8, 11-15, 18-20, 22-25 and 27-30 are consistent with damage that can occur when the blade contacts a hard surface such as the protective blade tray when product is improperly removed or inserted after use, or improper handling, or contact with another instrument during surgery or set-up.The damage seen on the returned complaint samples could have contributed to the customers reported issue of dull knife.The returned opened samples 7, 9, 10, 16, 17, 21, 26 were found to be visually and functionally conforming, therefore dull blades as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.Samples 7, 9, 10, 16, 17, 21, 26 met specifications.The exact root cause for the damaged knife samples is unknown for samples 1-6, 8, 11-15, 18-20, 22-25 and 27-30 , therefore specific action with regards to this complaint cannot be taken.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Any nonconformance, such as the damaged tip and damaged cutting edge exhibited on the returned opened sample, is removed from the lot and scrapped.Functional penetration testing is performed and monitored during the finishing process to ensure the sharpness of the product.The manufacturer internal reference number is: (b)(4).

• 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: 20607455
• Report Number: 2523835-2024-02295
• Device Sequence Number: 8144697
• Product Code: HNN
• UDI-Device Identifier: 00380659120015
• UDI-Public: (01)00380659120015(17)290131(11)240208(10)16J7U2
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 01/29/2025

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: 16J7U2
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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