FDA UDI
In Commercial Distribution
🇺🇸 United States
EVO/EVO+VISIAN Implantable Collamer Lens
DI: 00840311308569
·
Model: VTICM5 12.6 (-5.0/2.5)
·
STAAR SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EVO/EVO+VISIAN Implantable Collamer Lens
- Primary DI
- 00840311308569
- Version / Model
- VTICM5 12.6 (-5.0/2.5)
- Catalog Number
- VTICM5 12.6
- Company Name
- STAAR SURGICAL COMPANY
- Labeler DUNS
- 054751110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-28
- Public Version
- 1
- Public Version Date
- 2023-12-06
- Public Version Status
- New
- Public Device Record Key
- a5c84ada-1739-4d53-95c6-cb057287506f
Device Description
VTICM5 - Diopter: -5.0; Cylinder 2.5; Overall Diameter (Length): 12.6
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QCB | Phakic Toric Intraocular Lens | Ophthalmic | 886.3600 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47413 | Posterior-chamber intraocular lens, phakic | An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to provide refractive correction of vision, typically in the treatment of myopia or hyperopia, without removal of the natural lens (crystalline lens). The device is typically made of a synthetic polymer; it is also referred to as an implantable contact lens (ICL). Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840311308569 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030016 | 035 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius