Ophthalmic Surgical Knives Recalled Due to Sharpness Complaint Reports
Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic surgical knives (Model 8065752438) due to increased complaint reports about sharpness.
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 recall of a surgical instrument with reported quality concerns affecting sharpness. This represents a risk-of-harm product per the rubric, but no adverse events or injuries have been reported, placing it at the 'High' level.
Plain-English summary
Alcon Research LLC is recalling specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic surgical knives (Model 8065752438) due to an increase in complaint reports related to sharpness. A total of 4,766 units are affected.
The knives were distributed nationwide in the United States and to 49 other countries including Canada, Australia, and European nations. Affected lot numbers are 16C9RF, 16DDFT, 16DDFU, 16HE6E, 16HE6F, and 16HYDW.
Users should contact Alcon for information regarding this recall. Healthcare facilities and practitioners should verify their product inventory against the affected lot numbers.
The recalled product
- Product
- Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 4,766
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: 8065752438
- UDI-DI: 380657524389
- Lot numbers: 16C9RF
- 16DDFT
- 16DDFU
- 16HE6E
- 16HE6F
- 16HYDW.
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.
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