The Food and Drug Administration (FDA) has issued Bausch & Lomb a report detailing its observations at the conclusion of the inspection of the
Bausch & Lomb has proposed the ReNu with MoistureLoc formulation as the potential root cause of the increased relative risk of Fusarium keratitis. The observations from the FDA inspection, which may indicate deviations from current good manufacturing practice, do not necessarily support a connection between the formulation of the ReNu with MoistureLoc product and the Fusarium keratitis infections.
It is important to point out FDA's inspectional observations are preliminary and will need to be further evaluated before any conclusions can be drawn about such a connection. It is premature to conclude that some of the observations cited in the report are associated with the cases of Fusarium keratitis. Once the Establishment Inspection Report (EIR) will be written, and documentation reviewed, the FDA says it will be in a better position to evaluate its options.