ClearanceBrief
Recall Z-1201-06 ยท LPN Accessories, Soft Lens Products

Bausch & Lomb

Bausch & Lomb * ReNu with MoistureLoc, Multi-purpose soft contact lens solution * Sterile * Manufactured by: Bausch & Lomb, Rochester, NY 14609.

DateAug 31, 2006 (initiated Apr 13, 2006)
StatusTerminated
ReasonReports of Fusarium Infections among contact lens wearers.
Root causeComponent design/selection
ActionPress release was issued 4/13/2006. Letters were sent via blast email to retailers, Pharmacists and Eye Care Practitioners on 04/14/2006.
Quantity3 million units
DistributionWorldwide, including USA, Latin America, and Asia
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.