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DT1 UV HEVL LS Flex Softer Surface (Preliminary Saline Holding Time Study …
DT1 UV HEVL LS Flex Softer Surface
Preliminary Saline Holding Time Study - Boundary Sample
Use boundary sample to check peroxide and additional surfactant interactions. Check peroxide content as a function of time after production
Notebook Record
GLP Cytotoxicity
test final saline iterations (plus control?) to be evaluated in the clinic
protocol / report with QA DHR review
This item is in question - we will not have lenses from LS flex GWS line available. What is the alternative?
Clinical Lens Fabrication / Release Testing and Report
protocol / report / DHR QA review
Screening 1 Day Rabbit Study - Boundary Sample, no control
Make sample (rejects from JCM) with boundary saline
Notebook Record
Stability
provide rationale for recommending shelf life based on DT1 UV HEVL toric shelf life in the risk assessment to support the <12 hr clinical trial
PAE in Saline after AC Study
Take processed lens (rejects from JCM), package into boundary saline sample, autoclave. Remove autoclave lens, place a new processed lens and autoclave again. Check lens surface.
Notebook Record
DT1 Thermal Softer Surface
PAE in Saline after AC Study
Take processed lens, package into boundary saline sample, autoclave. Remove autoclave lens, place a new processed lens and autoclave again. Check lens surface.
Notebook Record
Preliminary Saline Holding Time
Use boundary sample to check peroxide and additional surfactant interactions. Check peroxide content as a function of time after production
Notebook Record
Screening 1 Day Rabbit Study - Boundary Sample, no control
Make sample with boundary saline
Notebook Record
Stability
test 2 saline iterations in 45 degrees
protocol / report
GLP Cytotoxity
test final saline iterations (plus control?) to be evaluated in the clinic
protocol / report with QA DHR review
Clinical Lens Fabrication / Release Testing and Report
protocol / report / DHR QA review