Ophtec Capsular Tension Ring Models 276 and 275 and Stabileyes Models STBL2US and STBL13US
by Ophtec BV PMA
Active
PMA P030023
Overview
The device is an endocapsular ring indicated for the stabilization of weakened, broken or missing zonules suspected or observed during cataract extraction using phacoemulsification and continuous curvilinear capsulorhexis techniques in adults. It is designed to support the capsular bag and maintain lens position following implantation.
Supplied as a sterile, single-use implant. Manufactured by Ophtec BV in Groningen, Netherlands. Authorized under FDA PMA P030023. Distributed by Advanced Medical Optics as the Stabileyes capsular tension ring (Models STBL2US and STBL13US).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP030023 | Date27 Apr 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Ring, endocapsular
- PMA Number
- FDA Product Code
- MRJ
- Models / Variants
- Device Class
- Class III
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
Other devices from Ophtec BV
Questions
What is the primary intended use of the OPHTEC Capsular Tension Ring?
The device is indicated for the stabilization of weakened, broken or missing zonules that are suspected or observed during cataract extraction using phacoemulsification and continuous curvilinear capsulorhexis techniques in adults.
How are the OPHTEC Models 275 and 276 related to the Stabileyes models STBL2US and STBL13US?
The OPHTEC Capsular Tension Ring Models 275 (10/12 mm) and 276 (11/13 mm) are also known as the Stabileyes Capsular Tension Ring and are distributed by Advanced Medical Optics under the model designations STBL2US and STBL13US.
Is the OPHTEC Capsular Tension Ring reusable or single-use?
The device is supplied as a sterile, single-use implant intended for one-time use during cataract surgery.