Identity
- Trade Name
- SOFTEC HDO FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear) FDA UDI
- Model / Reference
- SOFTECHDO+34.0 FDA UDISOFTECHDO+26.5 FDA UDISOFTECHDO+17.5 FDA UDISOFTECHDO+12.5 FDA UDISOFTECHDO+27.5 FDA UDISOFTECHDO+31.0 FDA UDISOFTECHDO+28.0 FDA UDI
- Description
- IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear) FDA UDI
Identifiers
- Catalog Number
- SOFTEC HDO FDA UDI
- Primary DI / UDI-DI
- 00844369037693 FDA UDI00844369037587 FDA UDI00844369037259 FDA UDI00844369037105 FDA UDI00844369037600 FDA UDI00844369037662 FDA UDI00844369037617 FDA UDI
- PMA Number
- P090022 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Posterior-chamber intraocular lens, pseudophakic
Softec Hdo by Lenstec Barbados Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
P090022 also covers:
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lenstec Barbados Inc
Sources (7)
- FDA UDI 0c29f49c-83c1-4fee-b9f5-1e9cc8a4c3c2 38 fields · synced Jun 6, 2026
- FDA UDI 775e7592-d816-4f2c-9c36-f72a0380c9ce 38 fields · synced May 22, 2026
- FDA UDI 84448aa6-c488-4db2-9ef8-4dc24802a1e5 38 fields · synced May 24, 2026
- FDA UDI 4555376f-48ff-4ddc-8908-43a7664aad85 38 fields · synced May 25, 2026
- FDA UDI 76909d80-93f8-45c3-b0b5-03fdf12290f5 38 fields · synced May 25, 2026
- FDA UDI 50481a08-95a1-4b47-9b23-6b447327f8cf 38 fields · synced May 25, 2026
- FDA UDI fefb2174-1977-4fc9-8644-20d8f98a059c 38 fields · synced May 26, 2026