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.
Reason for recall: 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. Distribution: 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 Afr Quantity: 427,764 units Lot/code info: 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;
00380659215414
Official record: FDA (Device enforcement) ↗
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