FDA UDI
In Commercial Distribution
🇺🇸 United States
IC-8 Apthera IOL
DI: 00813359021035
·
Model: +25.0 D
·
Bausch & Lomb Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IC-8 Apthera IOL
- Primary DI
- 00813359021035
- Version / Model
- +25.0 D
- Catalog Number
- 82078-250
- Company Name
- Bausch & Lomb Incorporated
- Labeler DUNS
- 196603781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-04
- Public Version
- 2
- Public Version Date
- 2024-06-21
- Public Version Status
- Update
- Public Device Record Key
- 46902cf5-bd89-4dd3-b798-7788df0f31d3
Device Description
One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| POE | Extended Depth Of Focus Intraocular Lens | Ophthalmic | 886.3600 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61210 | Posterior-chamber intraocular lens, pseudophakic, extended-focus | A sterile optical device intended to be implanted into the posterior chamber of the eye to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. It consists of an intraocular lens (IOL) containing a small aperture inlay device designed to provide extended depth of focus for near vision, achieved through the pinhole effect. The components are typically made of synthetic polymer; 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 | 00813359021035 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P210005 | 000 |