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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82868

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 24, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Johnson & Johnson Surgical Vision Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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)

Z-1893-2019
Recall number
Z-1893-2019
Initiated
September 24, 2018
Classification
Class II
Status
Terminated
Quantity
392 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Packaging error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Number: 60084881 Mfg. date: 2017-09-05 Exp. date: 2020-09-05 UDI: (01)05050474534117 (17)200905(10)60084881

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.