Bausch & Lomb Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Bausch & Lomb Inc
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Bausch & Lomb Inc is recalling Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507 due to Reports have been received of stromal incursions after use of the product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports have been received of stromal incursions after use of the product.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MD, MN, NJ, SC
Page updated: Jan 10, 2026