Reported May 22, 2013 · Terminated

Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while…

Insight Instruments, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Insight Instruments, Inc. · 2580 Se Willoughby Blvd · Stuart, FL · 34994-4701

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot Numbers
    • M53157
    • M55115
    • M56929
    • M58551
    • M61862
Amount recalled
776

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 21, 2014 · Data as of Sep 19, 5:37 PM UTC

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