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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73767

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

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Event summary

Timeline bucket
October 06, 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

INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.

Z-1597-2016
Recall number
Z-1597-2016
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Recalling firm
Alcon Research, Ltd.
Quantity
6597 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.

Code information

Lot numbers: 1623139H, 1623140H, 1623138H, 1623141H, 1623765H, 1623148H, 1623766H, 1623767H, 1623768H, 1623142H

Distribution pattern

Nationwide Distribution.