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U.S. Department of Health and Human Services

Class 2 Device Recall Zyoptix

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  Class 2 Device Recall Zyoptix see related information
Date Initiated by Firm June 08, 2007
Date Posted August 02, 2007
Recall Status1 Terminated 3 on April 28, 2009
Recall Number Z-1022-2007
Recall Event ID 38230
510(K)Number K040204  
Product Classification ophthalmic surgical accessory - Product Code HNO
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.
Code Information All lots
Recalling Firm/
Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Ned Luce
Manufacturer Reason
for Recall
Reports have been received of stromal incursions after use of the product.
FDA Determined
Cause 2
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.
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.
510(K) Database 510(K)s with Product Code = HNO and Original Applicant = BAUSCH & LOMB, INC.