Hubble contact lens online company sold contact lenses to a (b)(6) y/o female who had never worn contact lenses ever before without a fitting and proper instruction.Pt wore contacts all day long which are low oxygen permeable and reused their daily disposable contact lenses due to lack of education and proper fitting.This occurred over a period of 4 to 6 months.In (b)(6) 2016 pt was initially seen and accepted higher spectacle prescription but felt too strong, within a few weeks came back.Today in (b)(6) 2020, she admitted she was using the hubble contacts which due to overuse and misuse may have cause increased and fluctuating prescription.Her risk of infection and blindness increased with this proper use.Also, hubble violated the contact lens policy that all pts need to be fitted by an eye care provider for contact lenses.(b)(4).Fda safety report id# (b)(4).
|