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U.S. Department of Health and Human Services

Class 2 Device Recall Zyoptix XP Epi Separator

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 Class 2 Device Recall Zyoptix XP Epi Separatorsee related information
Date Initiated by FirmJune 08, 2007
Date PostedAugust 02, 2007
Recall Status1 Terminated 3 on April 28, 2009
Recall NumberZ-1021-2007
Recall Event ID 38230
510(K)NumberK040204 K062465 
Product Classification ophthalmic surgical accessory - Product Code HNO
ProductBausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactured by: Bausch & Lomb Incorporated, St. Louis, MO. The Epi Separator 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
For Additional Information ContactNed Luce
585-338-6368
Manufacturer Reason
for Recall		Reports have been received of stromal incursions after use of the product.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce243/10-pouch cartons
DistributionDistribution 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 CycleTPLC 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) Database510(K)s with Product Code = HNO
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