Exact FDA event identifier

Event 67440

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

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Event summary

Timeline bucket: February 03, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Carl Zeiss Meditec AG

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

Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

Z-1153-2014

Recall number: Z-1153-2014
Initiated: February 03, 2014
Classification: Class II
Status: Terminated
Recalling firm: Carl Zeiss Meditec AG
Quantity: 1 package containing 10 individual treatment packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.

Code information

P/N 1462-333, Size M, Lot # M130010

Distribution pattern

US Distribution: NV only.