PMA P030016S028

Device
VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)
Applicant
STAAR Surgical Company
PMA number
P030016
Supplement
S028
Product code
MTA
Decision date
2015-11-17
Generic name
Lens, intraocular, phakic
Approval order statement
THE REPLACEMENT OF AN INSTRUMENT TO MEASURE DIOPTRIC POWER AND IMAGE QUALITY (MTF) AT FINAL PRODUCT INSPECTION.

Current openFDA PMA Record#

Device
VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)
Applicant
STAAR Surgical Company
PMA number
P030016
Supplement
S028
Product code
MTA
Generic name
Lens, intraocular, phakic
Decision date
2015-11-17
Decision code
OK30
Date received
2015-10-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
THE REPLACEMENT OF AN INSTRUMENT TO MEASURE DIOPTRIC POWER AND IMAGE QUALITY (MTF) AT FINAL PRODUCT INSPECTION.