Alcon ophthalmic surgical knives recalled for blade sharpness defects
Alcon is recalling specific ophthalmic surgical knives (ClearCut and A-OK models) from its Custom Pak system due to blade sharpness complaints affecting 384,851 units distributed nationwide and internationally.
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 is a Class II FDA recall of surgical instruments critical to ophthalmic procedures. Blade sharpness defects in surgical knives pose a risk of surgical complications and patient harm. No injuries or hospitalizations are explicitly reported in the source, but the existence of complaint reports indicates an actual product defect rather than a purely theoretical risk.
Plain-English summary
Alcon Research LLC is recalling specific ophthalmic surgical knives included in its Custom Pak sterile surgical procedure packages. The recall affects ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic knives due to an increase in complaint reports related to blade sharpness. A total of 384,851 units are affected by this Class II recall.
The affected Custom Pak surgical kits have been distributed nationwide in the United States and internationally to over 40 countries. The Custom Paks are designed for use by trained ophthalmic surgeons performing various eye surgery procedures.
Surgeons and healthcare facilities using these products should discontinue use of the affected ophthalmic knives. Patients who have undergone surgery with these instruments should contact their healthcare provider if they have concerns about their surgical outcome or experience any complications related to their eye surgery.
The recalled product
- Product
- Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries
- Manufacturer
- Alcon Research LLC
- Hazard
- surgical-blade-defect
- ophthalmic-knife-defect
- blade-sharpness
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 (20)
- UDI-DIs: H5301ALCON1CPAK10 and H5302ALCON2CPAK20
- Model Catalog numbers: 0210-71
- 0515-65
- 0613-84
- 0775-69
- 0835-60
- 0852-75
- 0884-77
- 0900-28
- 0972-31
- 0995-82
- 10027-12
- 10066-19
- 10068-19
- 10214-20
- 10214-21
- 10275-17
- 10308-11
- 10342-17
- 10477-21
Distribution
Distributed nationwide across the United States.
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