Z-1022-2007

Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic...

Name: Z-1022-2007 Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic...
Creator: Bausch & Lomb Inc
Published: 2007-06-08
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2007-06-08 / Terminated

FDA source

Bausch & Lomb Inc began a recall of Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the... on 2007-06-08. The reason FDA records is "Reports have been received of stromal incursions after use of the product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1022-2007
Status: Terminated
Initiated: 2007-06-08
Posted: 2007-08-02
Terminated: 2009-04-28
Recalling firm: Bausch & Lomb Incorporated
Product: Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. It does not reference the product as an Epi Head The product is labeled as Manufacturer: Bausch & Lomb Incorporated, Rochester, NY. The Epi Head is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.
Product code: HNO Keratome, Ac-Powered
Reason for recall: Reports have been received of stromal incursions after use of the product.
FDA root cause: Other
Action: The firm notified their customers via telephone between 6/8-12/07. During the call, the customer was informed reports had been received of stromal incursions and they were to quit using the product and return it.
Quantity in commerce: 29 Epi Heads
Distribution: Distribution was limited to "key" physicians in MN, SC, MD, and NJ. Foreign distribution was made to the firm's entities in The Netherlands, Singapore, Mexico, Canada, Hong Kong, and India.
Product codes and lots: All lots

Product code HNO

K040204Class IZyoptix Xp MicrokeratomeBausch & Lomb, Inc. / cleared 2004-03-22

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)