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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71630

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

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Event summary

Timeline bucket
April 15, 2015
Product types
Device
Classifications
Class I
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

ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.

Z-2323-2015
Recall number
Z-2323-2015
Initiated
April 15, 2015
Classification
Class I
Status
Terminated
Recalling firm
Alcon Research, Ltd.
Quantity
45,391

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.

Code information

Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.

Distribution pattern

Distribution Japan, No US distribution.