Exact FDA event identifier

Event 91389

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

Open FDA event record

Event summary

Timeline bucket: December 27, 2022
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: CooperVision, 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

MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.

Z-1014-2023

Recall number: Z-1014-2023
Initiated: December 27, 2022
Classification: Class II
Status: Ongoing
Recalling firm: CooperVision, Inc.
Quantity: 6,570 lenses

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.

Code information

Lot 6474502034 - packaged into 2 packaging lots: 21514501939036, 21514501972036 No UDI

Distribution pattern

Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.