BEUDAMED
    FDA Enforcement Class II Ongoing

    ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

    Recall: Z-1923-2024 · Reported June 5, 2024

    Enforcement

    Recall Number
    Z-1923-2024
    Event ID
    94501
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Alcon Research LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2024
    Initiation Date
    April 22, 2024
    Classification Date
    May 30, 2024
    Address
    Aspex Facility, 6201 South Fwy, Fort Worth, TX, 76134-2099, United States

    Description

    ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

    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 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;

    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 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.

    Quantity

    427,764 units