Insight Instruments

3 recalls •

💊 Drugs 🏥 Medical Devices

• Categories: Prescription Drugs, Other Medical Devices, Surgical Instruments

Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.

💊 Drugs Class I - Dangerous

Marketed without an Approved NDA/ANDA.

Apr 24, 2013 Prescription Drugs Nationwide View Details →

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.

🏥 Medical Devices Class I - Dangerous

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.

Jun 27, 2013 Other Medical Devices Nationwide View Details →

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.

🏥 Medical Devices Class I - Dangerous

Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.

Mar 15, 2013 Surgical Instruments View Details →