- Device
- MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES
- Applicant
- Carl Zeiss Meditec, AG
- PMA number
- P830056
- Supplement
- S079
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 1999-05-11
- Decision code
- APPR
- Date received
- 1998-11-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for posterior chamber intraocular lens models C451F, C421F, and C455A5. These lenses are intended to be used for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed using extracapsular extraction methods. The lenses are intended to be placed in either the ciliary sulcus or capsular bag.