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
M53157M55115M56929M58551M61862
- Lot Numbers
- 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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