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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70348

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

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Event summary

Timeline bucket
January 13, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Med-logics 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

ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.

Z-1268-2015
Recall number
Z-1268-2015
Initiated
January 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
Med-logics Inc
Quantity
360 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.

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

The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.

Code information

Lot 1490288

Distribution pattern

Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.