Z-1893-2019Class II

Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the...

Name: Z-1893-2019 Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the...
Creator: Johnson & Johnson Surgical Vision Inc
Published: 2018-09-24
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2018-09-24 / Terminated / root cause: packaging

FDA source

Johnson & Johnson Surgical Vision Inc began a recall of Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy... on 2018-09-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1893-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-24
Posted: 2019-06-28
Recalling firm: Advanced Medical Optics, Inc.
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)
Product code: MLZ Vitrectomy, Instrument Cutter
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.
Root cause tag: packaging
FDA root 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.
Product codes and lots: Lot Number: 60084881 Mfg. date: 2017-09-05 Exp. date: 2020-09-05 UDI: (01)05050474534117 (17)200905(10)60084881

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1893-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1893-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28

Product code MLZ

K081681Class IIVitrectomy Cutter and AccessoriesAdvanced Medical Optics, Inc. / cleared 2008-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)