Class 2 Device Recall Disposable 25GA Vitrectomy Cutter

• Date Initiated by Firm: September 24, 2018
• Create Date: June 28, 2019
• Recall Status: Terminated
• Recall Number: Z-1893-2019
• Recall Event ID: 82868
• 510(K)Number: K081681
• Product Classification: Vitrectomy, instrument cutter - Product Code MLZ
• Product: Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)
• Code Information: Lot Number: 60084881 Mfg. date: 2017-09-05 Exp. date: 2020-09-05 UDI: (01)05050474534117 (17)200905(10)60084881
• FEI Number: 3003843509
• Recalling Firm/ Manufacturer: Johnson & Johnson Surgical Vision Inc; 1700 E Saint Andrew Pl; Santa Ana CA 92705-4933
• For Additional Information Contact: Sherly Jules-Fleury; 877-266-4543
• Manufacturer Reason for Recall: Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.
• FDA Determined Cause: Packaging process control
• Action: The firm, Johnson & Johnson Vision, sent an"URGENT MEDICAL DEVICE RECALL" Letter dated September 20, 2018 overnight on September 20, 2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: If you have received impacted product, please immediately take the following actions: 1. Review your inventory to identify units of affected lot; 2. Stop using and remove from your inventory all affected lot; and 3. regardless if you do not have inventory, please complete the Customer Reply form and return product. If you have questions, please contact the firm at 1-877-166-4543.
• Quantity in Commerce: 392 units
• Distribution: US Distribution to states of: NC, NV, TX, NY, UT, C, MN, NY, WA, NJ, OH, NV, CA and Internationally to: Australia and Japan.
• Total Product Life Cycle: TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MLZ