Alcon Research LLC: ClearCut and A-OK Ophthalmic Knives Recalled for Reduced Sharpness

What You Should Do

1. Check your surgical inventory for Alcon ophthalmic knives and Custom Pak kits. Compare your catalog and lot numbers against the lists provided in this recall.
2. Specifically identify catalog numbers 8065771540, 8065751658, 8065830077, 8065771541, 8065772245, 8065772265, 8065772445, 8065772465, 8065772745, 8065911901, 8065912001, 8065921541, 8065982465, 8065983065, 8065983265, 8065990002, 8065992245, 8065992445, 8065992561, 8065992647, 8065992745, 8065992747, 8065992761, 8065993045, 8065993047, 8065000095, 8065000093, 8065751617, 8065751618, 8065751767, 8065752437, 8065752438, 8065752450, 8065752451, and 8065753106.
3. For Alcon Custom Paks, verify the UDI-DI codes H5301ALCON1CPAK10 or H5302ALCON2CPAK20 along with the specific model-lot combinations ranging from 0210-71 to 29433-01.
4. Immediately stop using any affected knives or packs and quarantine them to prevent clinical use in any surgical procedures.
5. Contact your Alcon representative or the Aspex Facility at 6201 South Fwy, Fort Worth, Texas, to facilitate the return of affected inventory and obtain replacements.
6. Health care providers should report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
7. Contact the FDA directly at 1-888-463-6332 if you have additional questions about this medical device recall.

Your Remedy Options

Affected Products