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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72434

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

Open FDA event record

Event summary

Timeline bucket
September 29, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Tekia, 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

TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

Z-0237-2016
Recall number
Z-0237-2016
Initiated
September 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Tekia, Inc.
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.

Code information

SN: U07310001 thru U07310040 , 07310050 thru U07310059

Distribution pattern

Internationally to Vietnam.