Z-1281-2013Class II

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

Name: Z-1281-2013 Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light...
Creator: Insight Instruments, Inc.
Published: 2013-03-15
License: https://open.fda.gov/license/

Insight Instruments, Inc. / initiated 2013-03-15 / Terminated

FDA source

Insight Instruments, Inc. began a recall of Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites... on 2013-03-15. FDA classified it as Class II and gives the reason as "Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1281-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-15
Posted: 2013-05-10
Terminated: 2014-08-21
Recalling firm: Insight Instruments, Inc.
Product: 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.
Product code: HMX Cannula, Ophthalmic
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.
FDA root cause: Use error
Action: Insight Instruments, Inc. sent a recall letter dated March 15, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to do the following: 1)Perform a physical count of their inventory immediately for any of the recalled lots and complete and return the Return Response Form. 2) If they have any products listed, contact the firm at (800) 255-8354, to arrange for return and prompt replacement. 3) Discontinue using and dispensing all M.I.S. devices of the recalled lots.
Quantity in commerce: 776
Distribution: US Distribution IN and IL
Product codes and lots: Lot Numbers: M53157, M55115, M56929, M58551, M61862.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1281-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1281-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10

Product code HMX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)