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U.S. Department of Health and Human Services

Class 2 Device Recall CORNEA COAT

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  Class 2 Device Recall CORNEA COAT see related information
Date Initiated by Firm May 12, 2010
Date Posted August 13, 2010
Recall Status1 Terminated 3 on February 16, 2012
Recall Number Z-2220-2010
Recall Event ID 56246
Product Classification Ocular Surgery Irrigation Device - Product Code KYG
Product 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.
Code Information 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  
Recalling Firm/
Manufacturer		 Insight Instruments, Inc.
2580 Se Willoughby Blvd
Stuart FL 34994-4701
For Additional Information Contact
727-219-9393
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Packaging
Action All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.
Quantity in Commerce 16,128
Distribution Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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