Keratoconus Removal from DFU Contraindications Customer Letter, FINAL_8 JUN 2016- DEM
8 June 2016
Subject: Keratoconus Removed from Contraindications list for EVO Visian ICL™ (and related models) in CE Mark countries
Dear Dr. _______________
STAAR® Surgical announces that our European Regulatory Notified Body has recently concluded that keratoconus can be removed from the list of contraindications under the Contraindications section of the Visian ICL family Directions For Use (DFU).
Instead, there will be a precaution regarding implantation of the ICL in patients with keratoconus added to the Precautions section of the DFU. An example of a DFU with the new wording accompanies this letter. This change only applies to countries with the CE mark.
The ICL products currently in stock do not have this new wording yet, but it will be incorporated over time.
A third party ophthalmic expert contracted by our European Regulatory Notified Body concluded:
“There is more than enough evidence in the literature that the use of an ICL and/or toric ICL is effective and safe, and often the only option in improving the visual acuity in patients with Keratoconus. The literature review is complete and extensive and accurately describes the shift in clinical practice in the treatment of ametropia in keratoconus. The literature also accurately describes the areas of indications in terms of preoperative k values, refraction, grading of the keratoconus, and this is correctly left to the discretion and experience of the surgeons dealing with these problems."
STAAR appreciates your support and wanted to inform you about this important change in our product information. For further details, please contact our Clinical department at email@example.com.