PMA P910061S022
- Device
- SOFPORT/SOFLEX INTRAOCULAR LENSES
- Applicant
- Bausch & Lomb
- PMA number
- P910061
- Supplement
- S022
- Product code
- HQL
- Decision date
- 2015-11-05
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- CHANGING THE TENSILE FORCE TO BREAK SPECIFICATION, ADDING AN ELONGATION TO BREAK SPECIFICATION, AND ADJUSTING THE SAMPLING PLAN FOR OUR HAPTIC MATERIAL.
Current openFDA PMA Record#
- Device
- SOFPORT/SOFLEX INTRAOCULAR LENSES
- Applicant
- Bausch & Lomb
- PMA number
- P910061
- Supplement
- S022
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2015-11-05
- Decision code
- OK30
- Date received
- 2015-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGING THE TENSILE FORCE TO BREAK SPECIFICATION, ADDING AN ELONGATION TO BREAK SPECIFICATION, AND ADJUSTING THE SAMPLING PLAN FOR OUR HAPTIC MATERIAL.