The Fred Hollows Internal Ocular Laboratory established in 1994 in Eritrea by Fred Hollows, an Australian friend of Eritrea, is one of its kinds in the region. The foundation was established in Eritrea with a view to provide developing nations with the source of high-quality, low cost IOLs for use in lens replacement surgery. It is a high-tech pharmaceutical facility, designed specifically for the production of single-piece intra-ocular lenses and other sterile medical devises.
The lab was over engineered in order to guarantee the highest quality manufacturing facility and a finished product that would match world class standard. All manufacturing operations are conducted in class M5.5 clean rooms, while finished products packaging is conducted in class M3.5 laminar flow work stations.
The Fred Hollows IOL Lab. Is dedicated to manufacture high quality, single piece lenses and other eye problems cure which are affordable to eye care programs in developing countries. It is committed to providing world class IOLs and Pharmaceutical facilities, certified by Societe Generale de Surveillance (SGS).
At each stage in the IOL Manufacturing operation, quality control staff and on line quality assurances inspectors ensure that, from the time a raw material enters the production facility until its conversion into a finished lens complies with the code of Good Manufacturing Practice (GMP). These meet international Standards of GMP for the manufacture of intraocular lenses and are guaranteed by a comprehensive system of Standard Operating Procedures (SOPs) covering all areas of production, Quality Control, Quality Assurance, facility design, equipment maintenance and order processing.
The lab is equipped with modern Quality Control testing facilities, including its own in-house microbiological test Laboratory, performed in accordance with Good Laboratory Practice (GLP).
Quality is built into the product at every stage of the manufacturing process by an interlocutory set of over 400 written SOPs. The products are verified for several non-routine and re-validation tests by an external acknowledged independent world authority on the chemical and biological testing laboratory.
Fred Hollows IOLs are made of clinical grade Perspex CQUV. This and their design and finish ensure that the outcome for YAG capsulotomy to be excellent. The single piece technology provides the most flexible haptics of facilities easy insertion and rapid centration. They are lathe cut to computer controlled parameters, polished using revolutionary polishing system that guarantees the very best surface and edge finish available. Lenses are ethylene oxide sterilized and autoclaved in water for injection to ensure a product of the highest quality and efficacy.