Ophthalmic knives recalled for sharpness defects in ClearCut Safety Intrepid DB
Alcon is recalling 1,152 ClearCut Safety Intrepid DB 2.2 ophthalmic knives (Model 8065772265) due to complaint reports of sharpness defects.
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: FDA Class II recall of a surgical instrument with documented sharpness defects that impact surgical performance. While no injuries are reported in the source material, sharpness defects in ophthalmic knives represent a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
Alcon Research LLC is recalling 1,152 units of the ClearCut Safety Intrepid DB 2.2 ophthalmic knife (Model 8065772265) due to complaint reports of sharpness defects. The affected lot numbers are 15P7RH, 15P7RK, 15TFMJ, and 15V034.
Alcon has identified an increase in complaint reports related to the sharpness of these surgical instruments. Ophthalmic knives are used as precision surgical tools in eye procedures.
The affected units were distributed domestically and internationally to 51 countries including Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, United Arab Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, South Korea, Kosovo, Luxembourg, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Panama, Peru, the Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, and Uruguay.
Users and healthcare facilities should stop using affected units and contact Alcon or their healthcare provider for information about replacement or corrective action.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- blade-defect
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 (6)
- Model/Catalog Number: 8065772265
- UDI-DI: 00380657722655
- Lot numbers: 15P7RH
- 15P7RK
- 15TFMJ
- 15V034.
Distribution
Distributed nationwide across the United States.
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