Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1201-06

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

Bausch & Lomb Incorporated / initiated 2006-04-13 / Terminated / root cause: design

Bausch & Lomb began a recall of Bausch & Lomb * ReNu with MoistureLoc, Multi-purpose soft contact lens solution * Sterile * Manufactured by: Bausch & Lomb, Rochester, NY 14609 on . The reason FDA records is "Reports of Fusarium Infections among contact lens wearers". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1201-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bausch & Lomb Incorporated
Product
Bausch & Lomb * ReNu with MoistureLoc, Multi-purpose soft contact lens solution * Sterile * Manufactured by: Bausch & Lomb, Rochester, NY 14609.
Product code
LPN Accessories, Soft Lens Products
Reason for recall
Reports of Fusarium Infections among contact lens wearers.
Root cause tag
design
FDA root cause
Component design/selection
Action
Press release was issued 4/13/2006. Letters were sent via blast email to retailers, Pharmacists and Eye Care Practitioners on 04/14/2006.
Quantity in commerce
3 million units
Distribution
Worldwide, including USA, Latin America, and Asia
Product codes and lots
All lots, all sizes