SANTA FE, NEW MIXICO: Dr Sam Berne, a private practice physician in New Mexico is the man behind Dr Berne's Whole Health Products which he founded is recalling an eye drop brand.
He has been in the practice for more than 25 years. His whole health products improve vision and wellness as claimed on the website.
Why are Dr Berne's eyedrops being recalled?
However, the US Food and Drug Administration is recalling Whole Health Products of several eye drops following contamination from fungi and bacteria detected in the product.
"The recall applies to all lots of MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops and MSM MIST Drops 5% Solution," the FDA says as per Daily Mail.
The FDA discovered that one batch of the 5% solution was contaminated with both bacteria and fungi, and it did not pass a sterility test.
Dr Berne’s decided to recall several products "out of an abundance of caution".
He holds a Bachelor of Science from Pennsylvania State University, Doctor of Optometry from Pennsylvania College and did his postdoctoral work at the Gesell Institute in collaboration with Yale University.
How was the contamination in Dr Berne's eye drops found?
The FDA said there had been two 'adverse events' reported to the agency, but did not specify what they were
The products are used as lubricating eye drops and all recalled drops were available for purchase nationwide via Dr Berne's online store.
This recall, which affects several eye products, comes after earlier recalls this year. Those recalls were issued after at least one person died and 68 were blinded from using the products.
To recall and refund the products, Dr Berne’s is sending emails to its customers and distributors all over the country.
What can contaminated eye drops do?
According to the FDA, "using contaminated eye drops could result in minor to serious vision-threatening infection, which could possibly progress to a life-threatening infection."
Eye drops can get contaminated by different things during the production process, such as germs, rocks, or insects if the proper hygiene standards are not followed.
There have been several eyedrops recalled this year
Several eye products in the US have been recalled this year due to contamination issues.
Dr Berne’s products are the latest ones to join the list. Before that, EzriCare artificial tear drops were found to have P. aeruginosa, a hospital-acquired bacteria that can be fatal.
Delsam Pharma Artificial Eye Ointment also had a recall because of potential ‘microbial contamination’.
Other eye drops that were recalled for ‘non-sterility’ reasons include Brimonidine Tartrate Ophthalmic Solution and Purely Soothing 15% MSM Drops.
The contaminated eye products have caused 68 cases of blindness and at least one death in the US.
When did FDA issue the first warning against Dr Berne's eye drops?
Earlier, FDA issued a statement warning not to purchase Dr Berne's products on August 22.
It request to immediately stop using MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial and fungal contamination.
"FDA recommends consumers properly discard these products as FDA describes. Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection", the FDA said on August 22.
However, at the time the publication mentioned no adverse event was reported. The FDA added the products contain methylsulfonylmethane (MSM) as an active ingredient and were unapproved and being illegally marketed in the US.
The claims on the website about Dr Berne's products
The website claims Dr Berne's "whole health protocols improve vision and wellness by healing the mind-body-spirit through nutritional protocols, vision therapy, and self-care techniques."
However, at the bottom of the website is the disclaimer: 'These statements have not been evaluated by the Food and Drug Administration.
"This product is not intended to diagnose, treat, cure or prevent any disease".
