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Terminated

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.

FDA Recall Z-0144-2014 · Posted 2013-11-04

Recalling FirmInsight Instruments, Inc.
Recall StatusTerminated
Product CodeHNJ
Date Initiated2013-06-27
Date Terminated2017-09-27
Product Quantity10212

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.

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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