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Recall Observatory FDA recall evidence

Device product

Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2669-2024

July 15, 2024

Class II

Product summary

Firm
Alcon Research LLC
Event
Event 94989
Status
Ongoing
Classification
Class II
Quantity
11,676 units
Official record key
device-enforcement:Z-2669-2024

Official wording

Reason: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information: Model/Catalog Number: 8065993045; UDI-DI: 00380659930454; Lot numbers: 164RXE, 16F1PX.

Distribution pattern: Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.