Recall of Device Recall CORNEA COAT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Insight Instruments, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56246
  • Event Risk Class
    Class 2
  • Event Number
    Z-2220-2010
  • Event Initiated Date
    2010-05-12
  • Event Date Posted
    2010-08-13
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-02-16
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ocular Surgery Irrigation Device - Product Code KYG
  • Reason
    Insight instruments, inc., stuart, fl is recalling cornea coat 2.5% hydroxypropylmethylcellulose solution in 1.5 ml syringe due to a potential weakness of the peel pouch seals. products affected are item numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of biom pack.
  • Action
    All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.

Device

  • Model / Serial
    Product Item Lot # Cornea Coat Lot # Exp Date Cornea Coat M408080708 M408080708 2010-06 Cornea Coat M414420808 M414420808 2010-06 Cornea Coat M415940808 M415940808 2010-06 Cornea Coat M421610908 M421610908 2010-08 Cornea Coat M427661108 M427661108 2010-09 Cornea Coat M434311108 M434311108 2010-09 Cornea Coat M439690109 M439690109 2010-10 Cornea Coat M44744 M44744 2010-12
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.
  • Product Description
    CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. || Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. || REF 60010.000, QTY 14 - This package contains 14 individual packs, each containing 1 sterile, single use ocular irrigation device. For external use only! || Used as an ocular irrigation device.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Insight Instruments, Inc., 2580 Se Willoughby Blvd, Stuart FL 34994-4701
  • Manufacturer Parent Company (2017)
  • Source
    USFDA