PMA P010059S002

Device: CIONNI CAPSULAR TENSION RINGS
Applicant: Morcher GmbH
PMA number: P010059
Supplement: S002
Product code: MRJ
Decision date: 2005-10-14
Generic name: Ring, endocapsular
Approval order statement: APPROVAL FOR THE MORCHER CIONNI CAPSULAR TENSION RINGS (TYPES 1L, 2L, AND 2C). THE DEVICE IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK OR PARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION. CONDITIONS ASSOCIATED WITH WEAK OR PARTIALLY ABSENT ZONULES MAY INCLUDE PRIMARY ZONULAR WEAKNESS (E.G., MARFAN'S SYNDROME), SECONDARY ZONULAR WEAKNESS (E.G., TRAUMA OR VITRECTOMY), CASES OF ZONULYSIS, CASES OF PSEUDOEXFOLIATION AND CASES OF MARCHESANI'S SYNDROM.

Current openFDA PMA Record#

Device: CIONNI CAPSULAR TENSION RINGS
Applicant: Morcher GmbH
PMA number: P010059
Supplement: S002
Product code: MRJ
Generic name: Ring, endocapsular
Decision date: 2005-10-14
Decision code: APPR
Date received: 2004-08-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MORCHER CIONNI CAPSULAR TENSION RINGS (TYPES 1L, 2L, AND 2C). THE DEVICE IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK OR PARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION. CONDITIONS ASSOCIATED WITH WEAK OR PARTIALLY ABSENT ZONULES MAY INCLUDE PRIMARY ZONULAR WEAKNESS (E.G., MARFAN'S SYNDROME), SECONDARY ZONULAR WEAKNESS (E.G., TRAUMA OR VITRECTOMY), CASES OF ZONULYSIS, CASES OF PSEUDOEXFOLIATION AND CASES OF MARCHESANI'S SYNDROM.