Recall Z-2220-2010

Insight Instruments, Inc. · initiated May 12, 2010

Terminated

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.

Codes / lots: 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

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: Packaging

Action taken

All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.

Details

Recall number
Z-2220-2010
Initiated
May 12, 2010
Posted by FDA
August 13, 2010
Terminated
February 16, 2012
Product code
KYG – Device, Irrigation, Ocular Surgery
Quantity
16,128
Distribution
Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.
Recalling firm
Insight Instruments, Inc., Stuart, FL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2221-2010 BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope…Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in… 05/12/2010Terminated