Recall Z-1893-2019
Johnson & Johnson Surgical Vision Inc · initiated September 24, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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)
Codes / lots: Lot Number: 60084881 Mfg. date: 2017-09-05 Exp. date: 2020-09-05 UDI: (01)05050474534117 (17)200905(10)60084881
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 taken
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.
Details
- Recall number
- Z-1893-2019
- Initiated
- September 24, 2018
- Product code
- MLZ – Vitrectomy, Instrument Cutter
- Quantity
- 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.
- Recalling firm
- Johnson & Johnson Surgical Vision Inc, Santa Ana, CA