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Class 2 Device Recall Zyoptix |
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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
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Product Classification |
ophthalmic surgical accessory - Product Code HNO
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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/ Manufacturer |
Bausch & Lomb Inc 1400 North Goodman Street Rochester NY 14609-3547
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For Additional Information Contact |
Ned Luce 585-338-6368
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Manufacturer Reason for Recall |
Reports have been received of stromal incursions after use of the product.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = HNO and Original Applicant = BAUSCH & LOMB, INC.
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