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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68487

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

Open FDA event record

Event summary

Timeline bucket
June 03, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Alcon Research, Ltd.

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

eye-pak 7407 Tray Support Cover REF 8065740745

Z-2694-2014
Recall number
Z-2694-2014
Initiated
June 03, 2014
Classification
Class II
Status
Terminated
Recalling firm
Alcon Research, Ltd.
Quantity
2462

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility cannot be assured

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

The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.

Code information

Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.

Distribution pattern

Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.