Z-2220-2010

CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured by: Insight...

Name: Z-2220-2010 CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured by: Insight...
Creator: Insight Instruments, Inc.
Published: 2010-05-12
License: https://open.fda.gov/license/

Insight Instruments, Inc. / initiated 2010-05-12 / Terminated / root cause: packaging

FDA source

Insight Instruments, Inc. began a recall of CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994... on 2010-05-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2220-2010
Status: Terminated
Initiated: 2010-05-12
Posted: 2010-08-13
Terminated: 2012-02-16
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.
Product code: KYG Device, Irrigation, Ocular Surgery
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.
Root cause tag: packaging
FDA 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 in commerce: 16,128
Distribution: Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.
Product codes and 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

Product code KYG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)