Ophthalmic Surgical Knives Recalled by Alcon Due to Sharpness Defects
Alcon is recalling 3,721 units of its 25GA Valved Entry System ophthalmic knives due to complaint reports about sharpness. The devices were distributed nationwide and internationally to 50+ countries.
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: This FDA Class II medical device recall involves surgical instruments with a functional performance defect. While no illnesses or injuries have been reported, defective surgical instruments used in delicate ophthalmic procedures present a potential risk of harm, meeting the rubric criterion for High severity.
Plain-English summary
Alcon Research LLC is recalling approximately 3,721 units of its 25GA Valved Entry System ophthalmic knives (Model 8065751658, UDI-DI: 00380657516582) following detection of increased complaint reports about sharpness. The affected product is a valved trocar entry system used in ophthalmic surgery, with affected lot numbers 16C4MR, 16K84T, and 16FXTD.
Alcon detected an increase in complaint reports related to sharpness performance of the devices. This functional defect could potentially affect surgical outcomes in ophthalmic procedures.
The affected devices were distributed domestically throughout the United States and internationally to more than 50 countries including Argentina, Australia, Brazil, Canada, China, Japan, Mexico, the Philippines, South Korea, the United Kingdom, and others.
Healthcare providers and facilities using these devices should contact Alcon for instructions regarding replacement, repair, or return. Patients who underwent ophthalmic procedures using these instruments should consult their eye care provider if they have any concerns about their surgical outcome.
The recalled product
- Product
- Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 3,721
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 (5)
- Model/Catalog Number: 8065751658
- UDI-DI: 00380657516582
- Lot Numbers: 16C4MR
- 16K84T
- 16FXTD.
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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