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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65006

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

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Event summary

Timeline bucket
April 17, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Alcon Grieshaber 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

The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.

Z-1506-2013
Recall number
Z-1506-2013
Initiated
April 17, 2013
Classification
Class II
Status
Terminated
Recalling firm
Alcon Grieshaber AG
Quantity
8,455 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.

Code information

All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01

Distribution pattern

Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turkistan, Venezuela, and Veit Nam.