PMA P830056S078

Device: POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION)
Applicant: Carl Zeiss Meditec, AG
PMA number: P830056
Supplement: S078
Product code: HQL
Decision date: 1998-01-29
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Approval for lenses Models C440Z, U211M, UV91F, UV91F2, U691F, U691F2, C440U, C421F5, and C451F5. These lenses are intended to be used for primary implantation for the visula correction of aphakia in patients 50 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.

Current openFDA PMA Record#

Device: POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION)
Applicant: Carl Zeiss Meditec, AG
PMA number: P830056
Supplement: S078
Product code: HQL
Generic name: intraocular lens
Decision date: 1998-01-29
Decision code: APPR
Date received: 1996-07-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for lenses Models C440Z, U211M, UV91F, UV91F2, U691F, U691F2, C440U, C421F5, and C451F5. These lenses are intended to be used for primary implantation for the visula correction of aphakia in patients 50 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.