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The Patient Information Booklet provides data from FDA clinical trials including risks, contraindications, warnings and results. The FDA requires that every patient who is about to undergo LASIK surgery be given the Patient Information Booklet published by the laser manufacturer. Non-compliance with this FDA mandate is widespread. Each FDA-approved laser has an approval order with the Patient Information Do you know why eye doctors don't give this booklets to patients in the usa? How do you explain this huge 'worse symptoms' in ALL Patient Information Booklets?
Results from the last fda approved laser for lasik.
http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060004S001c.pdf
page 21
Change in best spectacle corrected visual acuity.
12 months - 1.1% - decrease at least 3 lines
2.3% - decrease 2 lines
17.8% - Decrease 1 line
page 28
Symptoms chart at 9 month.
Dryness - 26% -worse, 8.1% -significantly worse
Light sensitivity - 17.9% worse, 3.3% significantly worse
Halos - 14.6% worse, 3% significantly worse
Night driving vision - 14.6% worse, 4.2% significantly worse
Fluctuation of vision - 19.4% worse, 5.7% significantly worse
Compilation with symptoms tables from fda booklets.
https://docs.google.com/file/d/0B8wX_YuJzciZVUFVbUxoUUN4WDQ/edit?usp=sharing
Kind Regards,
ST3
Morris Waxler, PhD. From 1996 to 2000 was the FDA's chief scientist in charge of the clinical trials research for laser eye surgery. Now he says:
http://www.lasikcomplications.com/Waxler_petition_FDA_stop_LASIK(6Jan11).pdf
"FDA originally counted glare, halos, dry eye, night driving difficulties, and similar problems after excimer laser refractive surgery as adverse events, e.g. page 16 of the Patient Information Brochure for P970053c says “…adverse events beyond the first few months: night vision difficulty (48.1% at six months)…glare (34.4% at 6 months)…” LASIK manufacturers and their collaborators successfully pressured FDA to classify these problems as mere “symptoms” so that manufacturers could claim that the adverse event rate is less than one percent."
"LASIK manufacturers and their collaborators emphasized “patient satisfaction” to divert FDA attention from continuing LASIK-patient complaints about glare, halos, dry eye and night driving problems."
"To this moment they and their collaborators have been successfully engaged in a pattern of falsifying, misrepresenting, manipulating, and withholding safety and effectiveness data from FDA to make their LASIK devices appear safer than they are."
Results from the last fda approved laser for lasik.
http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060004S001c.pdf
page 21
Change in best spectacle corrected visual acuity.
12 months - 1.1% - decrease at least 3 lines
2.3% - decrease 2 lines
17.8% - Decrease 1 line
page 28
Symptoms chart at 9 month.
Dryness - 26% -worse, 8.1% -significantly worse
Light sensitivity - 17.9% worse, 3.3% significantly worse
Halos - 14.6% worse, 3% significantly worse
Night driving vision - 14.6% worse, 4.2% significantly worse
Fluctuation of vision - 19.4% worse, 5.7% significantly worse
Compilation with symptoms tables from fda booklets.
https://docs.google.com/file/d/0B8wX_YuJzciZVUFVbUxoUUN4WDQ/edit?usp=sharing
Kind Regards,
ST3
Morris Waxler, PhD. From 1996 to 2000 was the FDA's chief scientist in charge of the clinical trials research for laser eye surgery. Now he says:
http://www.lasikcomplications.com/Waxler_petition_FDA_stop_LASIK(6Jan11).pdf
"FDA originally counted glare, halos, dry eye, night driving difficulties, and similar problems after excimer laser refractive surgery as adverse events, e.g. page 16 of the Patient Information Brochure for P970053c says “…adverse events beyond the first few months: night vision difficulty (48.1% at six months)…glare (34.4% at 6 months)…” LASIK manufacturers and their collaborators successfully pressured FDA to classify these problems as mere “symptoms” so that manufacturers could claim that the adverse event rate is less than one percent."
"LASIK manufacturers and their collaborators emphasized “patient satisfaction” to divert FDA attention from continuing LASIK-patient complaints about glare, halos, dry eye and night driving problems."
"To this moment they and their collaborators have been successfully engaged in a pattern of falsifying, misrepresenting, manipulating, and withholding safety and effectiveness data from FDA to make their LASIK devices appear safer than they are."
