Bausch & Lomb Surgical, Inc. SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
Brand
Bausch & Lomb Surgical, Inc.
Lot Codes / Batch Numbers
8XRJ
Products Sold
8XRJ
Bausch & Lomb Surgical, Inc. is recalling SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens. due to Lens may be labeled with incorrect diopter size.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lens may be labeled with incorrect diopter size.
Recommended Action
Per FDA guidance
The firm telephoned direct medical facility consginees on 2/27/2004 instructing to determine the disposition of the lenses and to return unimplanted ones. Follow-up phone calls were made in March 2004 for unresolved consignees.
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 noticePage updated: Jan 10, 2026