Bausch & 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.
FDA Recall Z-1021-2007 · Posted 2007-08-02
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Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeHNO
Date Initiated2007-06-08
Date Terminated2009-04-28
Product Quantity243/10-pouch cartons
Reason for Recall
Reports have been received of stromal incursions after use of the product.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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