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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT
Classification Namelens, contact, orthokeratology, overnight
Generic Nameoprifocon a rigid gas permeable contact lenses
Regulation Number886.5916
ApplicantBAUSCH & LOMB
PMA NumberP010062
Supplement NumberS001
Date Received07/06/2004
Decision Date08/02/2004
Product Code
NUU[ Registered Establishments with NUU ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the protocol to be used to add contact lens finishing laboratories to manufacture the subject device. The device, as modified, will be marketed under the trade name boston orthokeratology (oprifocon a) shaping lens for overnight wear for bausch & lomb vision shaping treatment and is indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear for the temporary reduction of myopia up to 5. 00 diopters with eyes having astigmatism up to 1. 5 diopters. The lenses may only be disinfected using a chemical disinfection system. Note: to maintain the orthokeratology effect of myopia reduction, overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e. G. , night driving), visual fluctuations and changes in intended correction.
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