FDA Medical Device Recalls (openFDA)
Insight Instruments, Inc.: 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.
- Recall number
- Z-2220-2010
- Recalling firm
- Insight Instruments, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2010-05-12
- Posted
- 2010-08-13
- Terminated
- 2012-02-16
- 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.
- Root cause
- Packaging
- Action
- All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.
- Quantity
- 16,128
- Distribution
- Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYG
- Firm FEI
- 1052234
- Firm city
- Stuart
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28