Food, drugs, devices › Johnson & Johnson Surgical Vision Inc
Device recall: Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item neces
FDA enforcement event 82868 is a device recall by Johnson & Johnson Surgical Vision Inc of Santa Ana, CA, initiated 24 Sep 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated. Initiation: voluntary: firm initiated. Johnson & Johnson Surgical Vision Inc has 15 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Johnson & Johnson Surgical Vision Inc, Santa Ana, CA.
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
"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 records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1893-2019 | 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) | 392 units | Class II | Terminated | 10 Jul 2019 |
Context
Other enforcement events for Johnson & Johnson Surgical Vision Inc
All 15 events for Johnson & Johnson Surgical Vision Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 incision enlargement."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to states of: NC, NV, TX, NY, UT, C, MN, NY, WA, NJ, OH, NV, CA and Internationally to: Australia and Japan."
Is the recall still ongoing?
FDA lists the status as Terminated. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.