PMA P010062S007

Device: ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S007
Product code: NUU
Decision date: 2010-02-19
Classification: Lens, Contact, Orthokeratology, Overnight
Generic name: Lens, contact, orthokeratology, overnight
Approval order statement: APPROVAL OF LABELING CHANGES FOR THE BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS AS A RESULT OF THE POST-APPROVAL STUDY. THE DEVICE IS INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR AS PART OF BAUSCH & LOMB VISION SHAPING TREATMENT VST PROCESS FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING ASTIGMATISM UP TO 1.50 DIOPTERS.

Current openFDA PMA Record#

Device: ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S007
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2010-02-19
Decision code: APPR
Date received: 2009-10-13
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL OF LABELING CHANGES FOR THE BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS AS A RESULT OF THE POST-APPROVAL STUDY. THE DEVICE IS INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR AS PART OF BAUSCH & LOMB VISION SHAPING TREATMENT VST PROCESS FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING ASTIGMATISM UP TO 1.50 DIOPTERS.