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Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- Diopter: 16.0 Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDIDiopter: 11.0 Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDIDiopter: 12.0 Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDIDiopter: 13.5 Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
- Model / Reference
- AA4204VL FDA UDI
- Description
- Diopter: 16.0 Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDIDiopter: 11.0 Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDIDiopter: 12.0 Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDIDiopter: 13.5 Overall Diameter (Length): 11.2 mm (Longer Haptic) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841542101684 FDA UDI00841542101585 FDA UDI00841542101608 FDA UDI00841542101639 FDA UDI
- PMA Number
- P880091 FDA UDI
- FDA Product Code
- HQL FDA UDI
- GMDN Term
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.3600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Posterior-chamber intraocular lens, pseudophakic
Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens by Staar Surgical Co. — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Posterior-chamber intraocular lens, pseudophakic.
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- TECNIS IOL — Johnson & Johnson Surgical Vision, Inc. · Class III
- enVista Aspire™ Toric IOL — Bausch & Lomb Incorporated · Class III
- TECNIS SIMPLICITY — Johnson & Johnson Surgical Vision, Inc. · Class III
- enVista® Toric IOL — Bausch & Lomb Incorporated · Class III
Cleared under the same submission
P880091 also covers:
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens - Toric Optic — Staar Surgical Co.
- Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens - Toric Optic — Staar Surgical Co.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Staar Surgical Co.
Sources (4)
- FDA UDI aea2cbd0-c712-4e74-aad4-37c08f49270f 34 fields · synced Jun 1, 2026
- FDA UDI 15aa2e30-9ee9-4b29-8672-8f5dc7977d24 34 fields · synced May 25, 2026
- FDA UDI c4082f1b-250b-400a-a1e7-c64cb713158f 34 fields · synced May 27, 2026
- FDA UDI d3d0c9a3-ae70-473e-b7e3-b3e77bb68c72 34 fields · synced May 27, 2026