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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Ophthalmic Knife

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 Class 2 Device Recall Alcon Ophthalmic Knifesee related information
Date Initiated by FirmJuly 15, 2024
Date PostedAugust 16, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2652-2024
Recall Event ID 94989
Product Classification Knife, ophthalmic - Product Code HNN
ProductProduct Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Code Information Model/Catalog Number: 8065772445; UDI-DI: 00380657724451; Lot numbers: 15V018, 15V019, 15V01A, 15V01C, 15V01D, 15V036, 15W7UE, 15W7UF, 15W7UH, 15W7UJ, 15W996, 15W997, 161960, 161961, 161962, 161963, 167PR0, 167PT9, 168NM5, 168NM6, 168NM7, 168NN9, 168NNA, 168NNC, 168YFW, 169KL0, 169KL1, 169KL2, 169KL3, 169KTC, 169KTE, 169KTH.
Recalling Firm/
Manufacturer		 Alcon Research LLC
Aspex Facility
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information ContactKristen Kellerhals
1-817-5514047
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionOn July 15, 2024, URGENT: MEDICAL DEVICE FIELD CORRECTION letters were sent to customers. Actions to be taken by the Customer / User: Our records indicate that you have received affected sterile standalone knives/trocar entry systems, Vitrectomy/Combined Procedure Pak, or an Alcon Custom Pak with an affected knives/trocar entry system lot number. 1. If you received sterile standalone knives or trocar entry system, we are asking that you dispose of the affected ophthalmic knife/trocar entry system and use a replacement. Alcon is sending sufficient replacement quantities to cover your estimated remaining impacted inventory. 2. If you received a Vitrectomy/Combined Procedure Pak with affected trocar entry system lot numbers, we are asking that, upon opening your Vitrectomy/Combined Procedure Pak for surgical use, you remove and dispose of the affected trocar entry system and use a replacement trocar entry system. Alcon is sending sufficient replacement quantities to cover your estimated remaining impacted inventory. 3. If you received an Alcon Custom Pak with affected knife or trocar entry system lot numbers, we are asking that, upon opening your Custom Pak for surgical use, you remove and dispose of the affected knife or trocar entry system contained within your specific lot(s) of Alcon Custom Pak and use a replacement knife or trocar entry system. If you have a Custom Pak lot listed in Appendix 1, then one or two of the knives/trocar entry systems in your Custom Pak may be affected by the field correction. Please refer to the impacted lot list in Appendix 1 to ensure that the appropriate knife/trocar entry system is removed. Alcon is sending replacement quantities of knives and/or trocar entry system to cover your estimated remaining impacted inventory, and any future shipments of impacted Custom Pak lots. NOTE: Alcon surgical products are sterile and should not be opened before surgery. The remaining components of the Alcon Custom Pak are unaffected by thi
Quantity in Commerce29,814 units
DistributionDomestic: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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