Ophthalmic surgical knives recalled for sharpness defects
Alcon is recalling approximately 29,190 V-Lance ophthalmic surgical knives due to reports of blade sharpness defects. Affected instruments are distributed worldwide, including as components in Alcon Custom Pak surgical procedure packs.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with no reported illnesses or injuries, but sharpness defects in surgical instruments used in high-risk ophthalmic procedures qualify as risk-of-harm where injury has not yet been reported, meeting Score 3 criteria per the recall severity rubric.
Plain-English summary
Alcon Research LLC is recalling 20 Gauge V-Lance Knife (Model 8065912001) ophthalmic surgical instruments due to an increase in complaint reports related to blade sharpness. These surgical knives are used in ophthalmic procedures and are distributed both as standalone sterile instruments and as components within Alcon Custom Pak surgical procedure packs.
Approximately 29,190 units have been distributed worldwide, including throughout the United States and to 29 additional countries across Africa, Asia, Europe, and the Americas. Affected lot numbers include 15W9CJ, 161A10, 161A2M, 163701, 164WWX, and 16D4VU. Standalone sterile knives have been placed on hold, while units within Custom Pak sets continue to be distributed to prevent immediate market shortage and surgical cancellations.
Healthcare providers using affected instruments should verify blade sharpness before surgical use. Facilities with affected lot numbers should contact Alcon Research LLC for guidance on replacement, handling, or other appropriate measures.
The recalled product
- Product
- 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- blade-dullness
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Model/Catalog Number: 8065912001
- UDI/DI: 00380659120015
- Lot/Batch: 15W9CJ
- 161A10
- 161A2M
- 163701
- 164WWX
- 16D4VU
Distribution
Distributed nationwide across the United States.
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