In this document, you will have access to more information about the Keraring Intrastromal Corneal Ring Segment.

Product

The Keraring Intrastromal Corneal Ring Segment can be of three models: SI-5, SI-6, AS-5, AS-6 e SG.

Manufacturer

The Keraring Intrastromal Corneal Ring Segment is manufactured by the company Mediphacos Indústrias Médicas S.A., located at Avenida Deputado Cristovam Chiaradia 777, 30575-815, Belo Horizonte, MG – Brazil.

Authorized Representative

The Authorized Representative in the European Union is MDSS – Medical Device Safety Service, located in Schiffgraben 41, 30175, Hannover – Germany.

Postoperative follow-up

After implanting the Keraring Intrastromal Corneal Ring Segment you must follow all the ophthalmologist doctor’s instructions who performed the surgery.

You must use all post-operative medications, according to your Ophthalmologist doctor’s prescription. You must NOT rub your eyes after implantation to prevent Keraring from moving and leaving the incision (cut) and for the incision to heal completely. If you experience pain, irritation, a foreign body sensation, or a sudden change in your vision in the postoperative period, contact your Ophthalmologist doctor immediately. Do not miss any of the appointments that your doctor makes after the surgery, the postoperative follow-up should be performed to assess your vision and check for any surgical complications. If you do not follow the guidelines or do not attend consultations, your vision may be impaired.

Warnings, precautions or measures to be taken

The Keraring Intrastromal Corneal Ring Segment has no incompatibility with diagnostic devices or with scanners used in security controls or with environmental conditions.

After implantation of the Keraring Intrastromal Corneal Ring Segment may be necessary to use glasses or contact lenses. If you want to perform refractive surgery (a surgical procedure to correct refractive errors such as myopia, hyperopia, and astigmatism), as there is no evidence that refractive surgery is safe and effective after Keraring Intrastromal Corneal Ring Segment implant, check that the ophthalmologist who performed the surgery for Keraring Intrastromal Corneal Ring Segment implant agrees that refractive surgery can be performed after it assesses whether the benefits will outweigh the risks.

You may have difficulty seeing in places with medium or low light or you may have vision decreased after implantation of the Keraring Intrastromal Corneal Ring Segment, due to several reasons. If you notice that is having trouble seeing, contact your Ophthalmologist doctor immediately.

If you have difficulty seeing after implanting the Keraring Intrastromal Corneal Ring Segment, your ophthalmologist can remove (explant) or adjust the position of the Keraring Intrastromal Corneal Ring Segment, as the Keraring implant is reversible and adjustable. Furthermore, if Keraring is explanted, good results can be achieved with the implantation of a new Keraring Intrastromal Corneal Ring Segment.

The progression of keratoconus is not related to the performance of the Keraring Intrastromal Corneal Ring Segment, it is related to the evolution of the disease itself.

Lifetime

The Keraring Intrastromal Corneal Ring Segment has an estimated lifetime of at least 3 years after implantation. Elapsed this period your ophthalmologist will evaluate whether it is necessary to explant Keraring or not.

Implantable product information

The Keraring Intrastromal Corneal Ring Segment, manufactured with the raw material Polymethylmethacrylate (PMMA), was subjected to numerous laboratory tests to verify safety for patients. In laboratory conditions (exhaustive extraction test and chemical characterization of the leachable test) was shown that can be released the compound Bumetrizole (which is the UV blocker of the Keraring Intrastromal Corneal Ring Segment) and metal ions of Zinc.

The maximum concentration of the Bumetrizole compound released per individual was 2,952 μg/individual. This concentration is 31.9 million times lower than the limit considered tolerable for an adult and 4.5 million times lower than the limit considered tolerable for a child.

The maximum concentration of the Zinc compound released per individual was 0.117 μg/individual. This concentration is 94.8 million times lower than the limit considered tolerable for an adult and 13.5 million times lower than the limit considered tolerable for a child.

The results showed that the quantities of Bumetrizole and Zinc found in Keraring are, at least, least 4.5 million times less than tolerable by both an adult and a child, even considering the implantation of 2 (two) units of the largest Keraring model and considering one replacement every 3 years throughout the patient’s life. This result confirms that the Keraring Intrastromal Corneal Ring Segment does not have any toxicological risk.

Notified Body

Name: DNV GL PRESAFE AS

Number: 2460

Address: Veritasveien 3, N-1363 Høvik, Norway