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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64887

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

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Event summary

Timeline bucket
March 15, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Insight Instruments, 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.

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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

Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.

Z-1281-2013
Recall number
Z-1281-2013
Initiated
March 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
Insight Instruments, Inc.
Quantity
776

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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Reason for recall

Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.

Code information

Lot Numbers: M53157, M55115, M56929, M58551, M61862.

Distribution pattern

US Distribution IN and IL