Develops and manufactures intraocular lenses, custom iris prostheses and accessories for eye surgery – 100 % made in Germany.
HumanOptics Holding AG
Erlangen · Sankt AugustinNew on Amplifa
About HumanOptics
HumanOptics Holding AG is a German manufacturer of implants and accessories for eye surgery. The portfolio includes intraocular lenses (IOLs) for the treatment of cataracts – monofocal, toric, trifocal and trifocal-toric, some with blue light filter – as well as the foldable iris prosthesis ARTIFICIAL IRIS CUSTOMFLEX, which is custom-made by hand to match the patient's iris color. In addition, the company offers the standardized variant ARTIFICIAL IRIS SELECT in nine color combinations as well as single-use surgical knives, injectors, OR sets, trepanes and forceps, capsular tension rings and viscoelastic solutions. Manufacturing is done from hydrophilic acrylic; all business processes from development through production to shipping take place in Germany at the Erlangen and Sankt Augustin sites. In the validated manufacturing process, the lenses undergo multiple 100 % inspections. HumanOptics also delivers special solutions with extreme diopter values beyond market-standard limits and is represented with its products in more than 40 countries.
- Site
- Erlangen
- Processes
- Manufacturing of intraocular lenses (IOLs) - monofocal, toric, trifocal, trifocal-toric,, Handcrafted custom iris prosthesis (ARTIFICIAL IRIS CUSTOMFLEX®), individually matched to iris color, Standardized iris prosthesis ARTIFICIAL IRIS SELECT in nine predefined color combinations, Manufacturing of single-use surgical knives for eye surgery, Manufacturing of accessories for ophthalmological procedures: injectors, OR sets, trepanes &, Multiple 100 % inspections of every single IOL in the optimized and validated manufacturing process, Manufacturing of special solutions and extreme diopter values beyond market-standard limits (e.g., Development and calculation of IOLs (individual calculation service with
- Materials
- Hydrophilic Acrylic (IOL material), Hydrophilic Acrylic, Foldable Prosthesis Polymer
- Certificates
- EN ISO 13485:2016, EU QMS Certificate (MDR, Annex IX Chapters I and III), EN ISO 13485, EU QMS Certificate (MDR), 100 % inspection per IOL
- Industries
- Eye surgery / Ophthalmology (medical technology)
- 01
Development and design (including special solutions and custom
- 02
Manufacturing from hydrophilic acrylic in a validated production process
- 03
Multiple 100 % inspection of every IOL
- 04
Quality management (EN ISO 13485, MDR)
- 05
Sales and customer care (Customer Service, Application Service)
Materials & Processes
Hydrophilic Acrylic
Foldable material for intraocular lenses of the IOL platform (monofocal, toric, trifocal).
Foldable Prosthesis Polymer
Material of the custom-made iris prosthesis ARTIFICIAL IRIS CUSTOMFLEX.
Locations
Erlangen
DEHeadquarters: development, manufacturing and sales
- Materials
- Hydrophilic Acrylic
Sankt Augustin
DEDevelopment, manufacturing and sales
- Materials
- Hydrophilic Acrylic
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacturing of intraocular lenses (IOLs) - monofocal, toric, trifocal, trifocal-toric,Plastics | – | – | – | – | Hydrophilic Acrylic |
| Handcrafted custom iris prosthesis (ARTIFICIAL IRIS CUSTOMFLEX®), individually matched to iris colorPlastics | – | – | – | – | Foldable polymer (prosthesis material) |
| Standardized iris prosthesis ARTIFICIAL IRIS SELECT in nine predefined color combinationsPlastics | – | – | – | – | – |
| Manufacturing of single-use surgical knives for eye surgeryPlastics | – | – | – | – | – |
| Manufacturing of accessories for ophthalmological procedures: injectors, OR sets, trepanes &Plastics | – | – | – | – | – |
| Multiple 100 % inspections of every single IOL in the optimized and validated manufacturing processTesting | – | – | – | – | – |
| Manufacturing of special solutions and extreme diopter values beyond market-standard limits (e.g.Engineering | – | – | – | – | – |
| Development and calculation of IOLs (individual calculation service withEngineering | – | – | – | – | – |
Additional services
Quality
In the optimized and validated manufacturing process, all intraocular lenses undergo multiple 100 % inspections; every lens is checked and released several times. The quality management system is certified to EN ISO 13485 and holds an EU QM certificate under the MDR.
| Evidence | Erlangen | Sankt Augustin |
|---|---|---|
| EN ISO 13485 | ||
| EU QMS Certificate (MDR) | ||
| 100 % inspection per IOL |
History
Company active in eye surgery for more than 40 years (no founding year documented)
Introduction of the ARTIFICIAL IRIS more than 20 years ago
- 2024
FDA approval for ARTIFICIAL IRIS CUSTOMFLEX for the treatment of aniridia patients