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.

Class I - Dangerous

💊 Drugs Recalled: April 24, 2013 Insight Instruments Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Insight Instruments, Inc.
Reason for Recall:: Marketed without an Approved NDA/ANDA.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1056-2014

Related Recalls

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.

Insight Instruments

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.

Insight Instruments

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 →