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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCIONNI CAPSULAR TENSION RINGS
Generic NameRing, endocapsular
ApplicantMORCHER GMBH
KAPUZINERWEG 12
STUTTGART, WURTTEMBERG-BADEN D-703-7037
PMA NumberP010059
Supplement NumberS002
Date Received08/03/2004
Decision Date10/14/2005
Product Code MRJ 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
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