A-OK 19G V-Lance (Alcon) – Sharpness Complaint (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Brand
Alcon Research LLC Aspex Facility
Lot Codes / Batch Numbers
Model/Catalog Number: 8065911901, UDI-DI: 00380659119019, Lot numbers: 16F1KH, 16F1KJ, 16F1P7, 16FXNJ, 16J9AE.
Products Sold
Model/Catalog Number: 8065911901; UDI-DI: 00380659119019; Lot numbers: 16F1KH, 16F1KJ, 16F1P7, 16FXNJ, 16J9AE.
Alcon Research LLC Aspex Facility is recalling Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 due to Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Oph. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Recommended Action
Per FDA guidance
On July 15, 2024, URGENT: MEDICAL DEVICE FIELD CORRECTION letters were sent to customers. Actions to be taken by the Customer / User: Our records indicate that you have received affected sterile standalone knives/trocar entry systems, Vitrectomy/Combined Procedure Pak, or an Alcon Custom Pak with an affected knives/trocar entry system lot number. 1. If you received sterile standalone knives or trocar entry system, we are asking that you dispose of the affected ophthalmic knife/trocar entry system and use a replacement. Alcon is sending sufficient replacement quantities to cover your estimated remaining impacted inventory. 2. If you received a Vitrectomy/Combined Procedure Pak with affected trocar entry system lot numbers, we are asking that, upon opening your Vitrectomy/Combined Procedure Pak for surgical use, you remove and dispose of the affected trocar entry system and use a replacement trocar entry system. Alcon is sending sufficient replacement quantities to cover your estimated remaining impacted inventory. 3. If you received an Alcon Custom Pak with affected knife or trocar entry system lot numbers, we are asking that, upon opening your Custom Pak for surgical use, you remove and dispose of the affected knife or trocar entry system contained within your specific lot(s) of Alcon Custom Pak and use a replacement knife or trocar entry system. If you have a Custom Pak lot listed in Appendix 1, then one or two of the knives/trocar entry systems in your Custom Pak may be affected by the field correction. Please refer to the impacted lot list in Appendix 1 to ensure that the appropriate knife/trocar entry system is removed. Alcon is sending replacement quantities of knives and/or trocar entry system to cover your estimated remaining impacted inventory, and any future shipments of impacted Custom Pak lots. NOTE: Alcon surgical products are sterile and should not be opened before surgery. The remaining components of the Alcon Custom Pak are unaffected by thi
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026