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

FDA device recall Z-0144-2014 · posted 2013-11-04 · Terminated

Recall details

Recalling firm

Insight Instruments, Inc.

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.

Action taken

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.

Root cause

No Marketing Application

Status

Terminated

Product code

HNJ

Quantity affected

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.

Date initiated

2013-06-27

Date posted

2013-11-04

Date terminated

2017-09-27

Location

Stuart, FL