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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97739

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

Open FDA event record

Event summary

Timeline bucket
September 30, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Alcon Research LLC

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

Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

Z-0326-2026
Recall number
Z-0326-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Alcon Research LLC
Quantity
82 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal
Sterility assurance reason.sterility_assurance · v1.0.0
seal in some units resulting in compromise in sterility

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

Potential for a weak seal in some units resulting in compromise in sterility.

Code information

GTIN: 00730822254946; Lot Number: A8041128

Distribution pattern

Worldwide - US distribution in the states of Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oklahoma, Oregon, Tennessee, Texas, Washington and the country of Canada.