Device product
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1923-2024
Product summary
- Event
- Event 94501
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 427,764 units
- Official record key
device-enforcement:Z-1923-2024
Official wording
Reason: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Code information: Model/Catalog Number: 8065921541; UDI/DI: 00380659215414; Lot/Batch: 15W7XT, 15W7Y8, 15W7Y9, 15W9E6, 15W9E8, 15X5JJ, 15X56A, 15X56C, 15X5KV, 15X5KX, 1618UH, 1618UJ, 161A1K, 1618V4, 1618V5, 161A21, 161A22, 162WY5, 162WY6, 162WYL, 162WYN, 1636Y8, 1636Y9, 1636YV, 164RXL, 164RY8, 164RYA, 164WV3, 164WW9, 164WWC, 1668MR, 1668MT, 1668NH, 1668NJ, 1668NK, 166E89, 166E90, 166E91, 167PVK, 167R34, 167PW7, 167PW8, 167PW9, 167R3K, 167R3L, 168TE8, 168UEX, 168TEN, 168UFJ, 168UFL, 169L38, 169L3M, 169P3C, 169P3D, 16ALXE, 16ALXF, 16AM34, 16ALY0, 16AM36, 16AV03, 16AV1T, 16DFKA, 16DFXT, 16DFL0, 16DFY7, 16DFY8, 16DNJ4, 16DNJN, 16DNJP, 16DNP3, 16DNP4, 16EM6V, 16EM6W, 16JAVH, 16JAVJ, 16JAVK, 16JAVL, 16JAVM;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom. Product distributed as sterile stand-alone knives have been placed on HOLD. Product included within Alcon Custom Pak (surgical procedure pack) are continuing to be distributed as ceasing distribution would cause immediate market shortage and result in canceled surgeries.
Derived failure modes
-
Unknown
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.