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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67385

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

Open FDA event record

Event summary

Timeline bucket
January 28, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AMO Puerto Rico Manufacturing, 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

AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.

Z-1123-2014
Recall number
Z-1123-2014
Initiated
January 28, 2014
Classification
Class II
Status
Terminated
Quantity
169 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.

Code information

1000001310 1000601310 1230911309 1231211309 1231511309 1231811309 1000011310 1000311310 1000611310 1230921309 1231221309 1231521309 1231821309 1000021310 1000321310 1000621310 1230931309 1231231309 1231531309 1231831309 1000031310 1000331310 1000631310 1230941309 1231241309 1231541309 1231841309 1000041310 1000341310 1000641310 1230951309 1231251309 1231551309 1000051310 1000351310 1000651310 1230961309 1231261309 1231561309 1000061310 1000361310 1000661310 1230971309 1231271309 1231571309 1000071310 1000371310 1000671310 1230981309 1231281309 1231581309 1000081310 1000381310 1000681310 1230991309 1231291309 1231591309 1000091310 1000391310 1000691310 1231001309 1231601309 1000101310 1000401310 1000701310 1231011309 1231311309 1231611309 1000111310 1000411310 1000711310 1231021309 1231321309 1231621309 1000121310 1000421310 1000721310 1231031309 1231331309 1231631309 1000131310 1000431310 1000731310 1231641309 1000141310 1000441310 1000741310 1231051309 1231351309 1231651309 1000151310 1000451310 1000751310 1231061309 1231361309 1231661309 1000161310 1000461310 1000761310 1231071309 1231371309 1000171310 1000471310 1000771310 1231081309 1231381309 1231681309 1000181310 1000481310 1000781310 1231091309 1231391309 1000191310 1000491310 1000791310 1231101309 1231401309 1231701309 1000201310 1000501310 1000801310 1231111309 1231411309 1231711309 1000211310 1000811310 1231121309 1231421309 1231721309 1000221310 1000521310 1000821310 1231131309 1231431309 1000231310 1000531310 1000831310 1231141309 1231441309 1231741309 1000241310 1000541310 1231151309 1231451309 1231751309 1000251310 1000551310 1231161309 1231461309 1231761309 1000261310 1000561310 1231171309 1231471309 1231771309 1000271310 1000571310 1231181309 1231481309 1231781309 1000281310 1000581310 1231191309 1231491309 1231791309 1000291310 1000591310 1231501309 1231801309

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.