PMA P010059S003

Device: MORCHER CAPSULAR TENSION RINGS
Applicant: Morcher GmbH
PMA number: P010059
Supplement: S003
Product code: MRJ
Decision date: 2009-05-22
Generic name: Ring, endocapsular
Approval order statement: APPROVAL FOR THE ADDITION OF CAPSULAR TENSION RINGS (CTRS) MODELS1G, 2S, 6D, 6E, AND 10C AND CHANGE IN PACKAGING TO INCORPORATE THE MORCHER INJECTOR PRELOADED WITH CTR MODELS 14, 14A, AND 14C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MORCHER CAPSULAR TENSION RINGS (MODELS 1G, 2S, 6D, 6E, AND 10C) AND EYEJET CTR AND IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK ORPARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRACTION WITH INTRAOCULAR LENSIMPLANTATION. CONDITIONS ASSOCIATED WITH WEAK OR PARTIALLY ABSENT ZONULES MAY INCLUDE PRIMARYZONULAR WEAKNESS (E.G., MARFAN'S SYNDROME), SECONDARY ZONULAR WEAKNESS (E.G., TRAUMA ORVITRECTOMY), CASES OF ZONULYSIS, CASES OF PSEUDOEXFOLIATION AND CASES OF MARCHESANI¿S SYNDROME.

Current openFDA PMA Record#

Device: MORCHER CAPSULAR TENSION RINGS
Applicant: Morcher GmbH
PMA number: P010059
Supplement: S003
Product code: MRJ
Generic name: Ring, endocapsular
Decision date: 2009-05-22
Decision code: APPR
Date received: 2007-03-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF CAPSULAR TENSION RINGS (CTRS) MODELS1G, 2S, 6D, 6E, AND 10C AND CHANGE IN PACKAGING TO INCORPORATE THE MORCHER INJECTOR PRELOADED WITH CTR MODELS 14, 14A, AND 14C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MORCHER CAPSULAR TENSION RINGS (MODELS 1G, 2S, 6D, 6E, AND 10C) AND EYEJET CTR AND IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK ORPARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRACTION WITH INTRAOCULAR LENSIMPLANTATION. CONDITIONS ASSOCIATED WITH WEAK OR PARTIALLY ABSENT ZONULES MAY INCLUDE PRIMARYZONULAR WEAKNESS (E.G., MARFAN'S SYNDROME), SECONDARY ZONULAR WEAKNESS (E.G., TRAUMA ORVITRECTOMY), CASES OF ZONULYSIS, CASES OF PSEUDOEXFOLIATION AND CASES OF MARCHESANI¿S SYNDROME.