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A UV Projector That Helps The Blind to See
Ophthalmologists combat cataract blindness
Goal: a cataract-free eye with good visual acuity
Calhoun Vision's Light Adjustable Lens (LAL®)
Intraocular lens location
Adjusting the Power of an Implanted LensOur customer, Calhoun Vision Inc., is a startup with a great idea: an IOL that can be adjusted in focus and power – even correcting astigmatism – non-invasively, after being implanted in the patient's eye. They call it the Light Adjustable Lens (LAL®). This remarkable technology allows surgeons to adjust for errors in the preoperative measurements and unforeseeable variations in the way the eye's wound heals.
The LAL is a 3-piece silicone lens composed of photosensitive materials called macromers that are sensitive to and react to UV-light of a specific wavelength. When the macromers are irradiated by UV light, they photopolymerize, altering the shape and curvature of the lens. By projecting patterned UV light on the LAL, the curvature of the lens can be customized.
By reshaping the LAL, the patient's eye can be adjusted for far or near vision, even creating a bifocal lens. Calhoun's LAL and UV 'curing' process are in commercial use in Europe and Mexico, and are currently going through phase III FDA trials in the US.
Shining Ultraviolet Light Into the Eye?ZYGO's part in the process is to assemble the projection optics and put together the final assembly of the full curing workstation: the doctor's tool to shine focused patterns of UV light on the implanted LAL. The consequences of a mistake are potentially dangerous – uncontrolled exposure of UV light at high power could permanently damage the retina. Strict quality controls are needed.
With human sight at stake in the procedure, ZYGO's electro-optical assembly facilities required an ISO-13485 certification for medical device assemblies. Because the system is still in trials, an FDA certification for following record-keeping and consistency procedures was also needed. ZYGO's electro-optical assembly group met both standards.
As an example of how closely ZYGO controls these processes, when the manufacturing was relocated from a leased building to a new, larger plant in 2013, the production process needed to be duplicated and recertified. Using Copy Exact techniques, ZYGO recreated the production in the new location, then an inspection and audit was performed by the customer and the FDA, recertifying ZYGO's assembly process with high marks.
Assembling a Medical Electro-Optical UV Projection SystemThe optical assembly inside the workstation contains the beam-handling, beam patterning, and projection optics. But the components are highly varied in nature and complexity: there's a high-power UV LED source with fiber optics, a PC, and a transformer with an uninterruptible power supply (UPS). A touchscreen monitor and keyboard interface controls the exposure software and a printer documents the procedures as well as doctor's notes for retesting. All of these elements need to be assembled and then combined into the final work station assembly. Our familiarity with high-power light sources, electronics, and quality assurance come into play in successfully combining elements and qualifying each delivered unit.
The Business End: The Optical HeadThe optics inside the projection unit are tested, assembled and aligned by ZYGO, and then performance is qualified. The light is delivered by fiber optical cable from the UV source. The beam is patterned in the optical head using a Digital Light Projector, and focused to the LAL in the eye. An LED inspection lamp rings the objective lens. The optical head sits atop a standard slit lamp base, modified by ZYGO to include a circuit board. The ophthalmologist uses the slit lamp system to examine the eye and positioning the patient's lens.
Meeting our client's concernsAs a medical start-up – for a new ophthalmology treatment – our client is responsible for rigorous testing and record-keeping, an obligation that ZYGO recognizes and fulfills. When we took on the project, we provided a desk in our facility for their engineer to review our process and verify our training on their product. We reverse-engineered the prototype to be able to manufacture the system, and set up an assembly procedure.
As further FDA testing continues, ZYGO's role is to maintain the process and reliably produce high quality outcomes, time after time. Every system in the field needs to be identical: in components, performance and results. Yet, FDA trials are lengthy and subject to unpredictable delays. This means having a partner who will go the extra mile to cope with risks, like electronic component obsolescence and revised delivery schedules, produces peace of mind. With ZYGO's customer-oriented focus, our client was able to move their system through trials without worrying that we'll be out of sync with their needs.
Whether for the requirements of biomedical, semiconductor, defense, or consumer electronics, ZYGO business systems are key to a successful OEM electro-optical assembly.
Hope for the futureAn artificial lens that can be safely adjusted after implantation – its power changed inside the eye – without further invasive surgery. It's pretty cool. Imagine a technology where lens implants can be adjusted up to two diopters after implantation, where vision can be corrected non-invasively, in a doctor's visit or two. After saving their vision from cataracts, patients may no longer require corrective glasses – potentially possessing near, intermediate, or distance vision.
Infant technologies like these, needed to make new medical devices a reality, require a long-term partner – one who is able to scale up with you – from prototype through production. But just as important, a partner who is committed to your success, whether it means high-quality certifications, or the honest feedback and advice you need to improve your chances.
(Images of the light adjustable lens and the UV projection system on this web site are used with permission of Calhoun Vision, Inc.)
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