FDA sampling and testing found bacterial and fungal contamination in Dr. Berne's and LightEyez eye drops which could carry risks of vision loss and death.
Plaintiff says treatments were ineffective at battling the severe pain and progression of the eye infection caused by EzriCare Artificial Tears, leaving surgical eye removal as the only alternative.
Many over-the-counter products in the U.S., like the recently recalled Artificial Tears eye drops, are allowed to be sold to consumers on a sort of "honor system", according to the report.
Plaintiff experienced increasing pain, burning and blurred vision after using recalled EzriCare drops, which were contaminated with bacteria.
Plaintiff's vision has continued to deteriorate, according to the Artificial Tears infection lawsuit, which may require a corneal transplant.
Plaintiff indicates there was no way of knowing EzriCare Artificial Tears eye drops were contaminated, which led to a severe eye infection and sepsis.
Plaintiff indicates Artificial Tears eye drops bacterial contamination led to the complete loss of vision in her right eye within a matter of months.
At least four patients have also had to have an eye surgically removed due to infections caused by recalled Artificial Tears eye drops, the CDC reports.
The FDA has given manufacturers of eye drops containing amniotic fluid 30 days to respond to a letter indicating they are selling unapproved medical products.
Investigators found multiple failures in quality control and sterility assurance, which could result in contamination problems at eye drops manufacturing plant in India
