EYE PCR - fixOflex
Information for Patients
Manufacturer: EYE-PCR B.V., Amsterdam, The Netherlands
Website: https://eyepcr.com
What is Cataract?
Cataract is when the lens inside your eye becomes cloudy or opaque, making it harder to see clearly. Things may look blurry, hazy, or less colorful. Cataracts usually develop slowly as we age, and they are a common cause of vision problems in adults.
How is Cataract treated?
Cataract is treated with surgery that removes the cloudy (opacified) natural lens of the eye. In its place, a small artificial lens—called an intraocular lens or IOL—is implanted to restore vision.
During the procedure, the cloudy lens material is removed, but the surrounding lens capsule (a thin, transparent membrane) is usually left in place. A small opening is made in the front of the capsule to allow the lens material to be taken out, and the IOL is inserted through this opening and positioned inside the capsule.
Cataract surgery is generally safe and the complications are usually minor.
The IOL has tiny flexible arms, called haptics, that help center and stabilize it within the capsule. However, in some cases—such as when the capsule is not perfectly symmetrical—the IOL may not center perfectly.
Over time, the capsule itself may become cloudy again, a common condition called posterior capsule opacification. This can blur vision but is usually treated easily with a quick, painless laser procedure (YAG laser capsulotomy), without the need for further surgery.
In some cases, the capsule may shrink or contract after surgery, which can cause the IOL to shift slightly. If this shift is significant, it can lead to visual disturbances and may require further evaluation or treatment.
For more detailed information on cataract surgery outcomes see below:
Frequent Issues and Side Effects Following Cataract Surgery
Posterior Capsule Opacification (PCO): Up to 50% of patients may develop PCO within 2 - 5 years which is sometimes called a “secondary cataract”. PCO causes cloudy vision after surgery and it is treated with additional laser procedure. Up to 37% may undergo Nd:YAG laser capsulotomy.
Refractive Error & Surprise
Depending on the IOL, up to 47.6% of patients may require glasses due to postoperative refractive surprise.
64% of patients implanted with a multifocal IOL are suffering from residual refractive error.
Loss of intracapsular volume and capsular fibrotic effects are complicating the replacement of an IOL.
Additional Complications
49% of patients will experience some aspect of dysphotopsia.
0.21% to 1.40% incidence rate of capsular bag phimosis.
0.2% to 3% incidence rate of IOL dislocation.
27.3% complete PVD (Posterior Vitreous Detachment: a common condition where the vitreous pulls away from the retina ) with a 7-fold higher hazard risk ratio for progression to complete PVD.
What is fixOflex ?
fixOflex is an endocapsular ophthalmic implant device which works as a peripheral capsular reconstructor and it’s intended use is the intraocular lens stabilisation in cataract surgery. The design of fixOflex takes into account the anatomic dimensions of the capsule and apart from reshaping the capsule after cataract emulsification, it may delay the development of Posterior Capsule Opacification (PCO) after cataract surgery. Furthermore, the design allows the fitting of the majority of the intraocular lens implants used as the lens implant may be easily stabilised inside the endocapsular device.
How does fixOflex work?
By refilling and maintaining contact with the inner surface of the lens capsule, fixOflex adapts seamlessly to the size of the normal capsule. Its inner rim structures center and stabilize the optical part of the IOL.
Its implantation is similar to an IOL implantation using a standard injector. Following its placement, the surgical technique is identical to cataract or clear lens exchange surgery.
Benefits of fixOflex
By supporting the new lens and maintaining the shape of the capsule, fixOflex can:
Improve how well you see after surgery
Reduce the chances of needing additional procedures later
Lower the risk of common issues like blurry vision or lens movement
Who can get it?
Adults who’ve had their cloudy lens removed due to cataracts and need a new artificial lens (IOL).
fixOflex works with certain lenses and tools. Your surgeon can check eyepcr.com/qualified for the full list and advise for the best course of action.
Contraindications
Each case should be evaluated individually by the doctor. In many cases cataract surgery is not recommended at all.
Absolute contraindications: serious or advanced eye conditions that make the implant unsafe or unlikely to be helpful.
Progressive front-eye diseases (e.g., abnormal blood vessels on the iris, iris thinning)
Bleeding in the choroid
Advanced diabetic eye disease
Severe damage to the optic nerve
Advanced corneal disease or failure
Cataract from congenital rubella
Ongoing or recurring eye inflammation
Uncontrolled glaucoma
Active or returning eye infections (e.g., endophthalmitis)
Abnormally small eyes
Major weakness in the eye’s lens support system
Relative contraindications: conditions that might increase risk and need careful assessment.
Borderline corneal cell health
Irregular or unstable corneal surface (e.g., keratoconus)
Past eye injury or surgery with structural damage
Retinal diseases that affect vision
Systemic conditions that slow healing (e.g., poorly controlled diabetes, autoimmune diseases)
Possible Surgery Complications
These risks are similar to regular cataract surgery and include:
Fluid leaks from the surgical wound
Swelling or cloudiness in the cornea
Retinal detachment (serious issue at the back of the eye)
Lens moving out of place
Cloudiness or scarring after surgery
Eye infection
Inflammation
Need for further surgery
If you are experiencing any of the above, please contact your surgeon.
Packaging& Instructions For Use (IFU)
Each endocapsular device is supplied in a glass sterile vial, filled with pure water. The vial is sealed with a silicone stopper and aluminum metal cap. The vial is sealed in a sterile peel pouch. The product is steam sterilized.
The surgeon is fully equipped with a complete guide, including IFU and training materials, as well as a detailed post-operative follow-up for your safety and recovery.
The device should be unpacked only in sterile conditions (in the surgery room) and by a trained professional.
Problems or Complaints?
Any health care professionals i.e. customers, users of EYE-PCR B.V. products who have complaints or have experienced dissatisfaction in the product quality, durability, reliability, safety, effectiveness and/or performance should notify EYE-PCR B.V. by email info@eyepcr.com or by letter tο the address below. For more information contact: EYE-PCR B.V., Westerdoksdijk 423, 1013 BX, Amsterdam, the Netherlands +31202377777
Who should not get it?
Not recommended if you have:
Serious ongoing eye problems (e.g., bleeding, severe nerve damage, uncontrolled pressure, eye infections).
Birth defects related to the eye.
Inflammatory or autoimmune diseases.
History of eye trauma or surgeries that damaged the structure.
Poor healing ability due to conditions like uncontrolled diabetes.
The surgeon should assess if it’s safe for you individually.