Z-0144-2014Class II

MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for...

Name: Z-0144-2014 MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for...
Creator: Insight Instruments, Inc.
Published: 2013-06-27
License: https://open.fda.gov/license/

Insight Instruments, Inc. / initiated 2013-06-27 / Terminated

FDA source

Insight Instruments, Inc. began a recall of MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of... on 2013-06-27. FDA classified it as Class II and gives the reason as "The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0144-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-27
Posted: 2013-11-04
Terminated: 2017-09-27
Recalling firm: Insight Instruments, Inc.
Product: MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
Product code: HNJ Punch, Corneo-Scleral
Reason for recall: The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.
FDA root cause: No Marketing Application
Action: Insight Instruments, Inc. sent a letter dated April 8, 2013, via USPS priority mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue using and dispensing all affected product, perform a physical count of their inventory and complete the Return Response Form and fax to 772-219-9342. Customers were also instructed to call 800-255-8354 to arrange for return and prompt reimbursement. For questions regarding this recall call 727-219-9393.
Quantity in commerce: 10212
Distribution: Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.
Product codes and lots: Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017 04/2013 11007 M55285 07/2013 11007 M55869 08/2013 11007 M58610 12/2013 11007 M59575 02/2014 11007 M61781 05/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0144-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0144-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-04

Product code HNJ

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)