Z-1893-2019 Class II Terminated
FDA device recall Z-1893-2019 was initiated by Johnson & Johnson Surgical Vision Inc on September 24, 2018 and is designated Class II. 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, inclu… The recall status is terminated. Affected quantity: 392 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- September 24, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 392 units
Product Description
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)
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.
Distribution Pattern
US Distribution to states of: NC, NV, TX, NY, UT, C, MN, NY, WA, NJ, OH, NV, CA and Internationally to: Australia and Japan.
Code Information
Lot Number: 60084881 Mfg. date: 2017-09-05 Exp. date: 2020-09-05 UDI: (01)05050474534117 (17)200905(10)60084881