Ophthalmic surgical knives recalled due to reported sharpness defects
Alcon is recalling specific ophthalmic surgical knives due to reported sharpness defects. The recall affects 3,791 units distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device with reported increase in complaints related to sharpness. No injuries or illnesses are mentioned in the source. This is a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion per the rubric.
Plain-English summary
Alcon Research LLC is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives (Model 8065751767) due to reported issues with blade sharpness. The recall affects 3,791 units.
Alcon has detected an increase in complaint reports related to sharpness for these affected surgical instruments. The knives have been distributed nationwide in the United States and internationally to over 50 countries.
Affected units can be identified by the following lot numbers: 16C9ND, 16C9NE, 16C9NF, 16HE5R, and 16HYDK.
The recalled product
- Product
- Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- Affected units
- 3,791
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 (7)
- Model/Catalog Number: 8065751767
- UDI-DI: 380657517671
- Lot numbers: 16C9ND
- 16C9NE
- 16C9NF
- 16HE5R
- 16HYDK.
Distribution
Part of a larger recall action
This product is one of 36 recalled by Alcon Research LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 36 products in this recall →Related recalls
Same manufacturer · Alcon Research LLC
See all →- SevereGenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
- SevereSystane Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
- CriticalOphthalmic surgical packs recalled over incomplete seals affecting sterility
FDA (Devices) · 2025-12-31
- ModerateVitrectomy probe packs recalled with no reason stated in the record
FDA (Devices) · 2025-12-03
- HighInfusion line packs recalled over incomplete seals in sterile pouches
FDA (Devices) · 2025-11-05
Same hazard · blade defect
See all →- HighOphthalmic knives recalled for sharpness defects in ClearCut Safety Intrepid DB
FDA (Devices) · 2024-08-28
- HighOphthalmic Surgical Knives Recalled Due to Sharpness Defect
FDA (Devices) · 2024-08-28
- HighOphthalmic Surgical Knives Recalled for Potential Sharpness Issues
FDA (Devices) · 2024-08-28
- HighAlcon Ophthalmic Surgical Knives Recalled for Sharpness Defects
FDA (Devices) · 2024-08-28
- HighSurgical Knife Crescent Recall Due to Incorrect Blade Angle
FDA (Devices) · 2024-01-10
Similar recalls
- HighClearCut and A-OK ophthalmic surgical knives recalled for sharpness issues
FDA (Devices) · 2024-06-05
- HighAlcon ClearCut S and A-OK ophthalmic surgical knives recalled for sharpness defects
FDA (Devices) · 2024-06-05
- HighOphthalmic surgical knives recalled due to sharpness complaints
FDA (Devices) · 2024-06-05
- HighOphthalmic surgical knives recalled for sharpness defects
FDA (Devices) · 2024-06-05
- HighAlcon Custom Ophthalmic Surgical Procedure Packs Recalled for Mold
FDA (Devices) · 2021-04-07
- ModerateBausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
FDA (Devices) · 2018-03-14