FDA QUESTIONS FOR PANEL DISCUSSION
The sponsor has not performed the "standard" battery of biocompatibility testing on the device, and has proposed to use the clinical data to document the biocompatibility of the device. Do the adverse events and their rates reported in the PMA raise any safety concerns from your clinical perspective?
Patients with high myopia were not included in the U.S. clinical study. Do the data in the PMA support these proposed indications for use?
Do the clinical data presented in the PMA provide sufficient evidence of safety and effectiveness of the device for the proposed indications for use (taking into account the revisions in response to question 2, if any)?
Do you have any recommendations for revisions or additions to the labeling as proposed by the sponsor? Please consider the following issues in your deliberations:
- high myopia – lens extraction without IOL implantation
- progressiveness of syndromes such as pseudoexfoliation and Marfan’s
- late onset of dislocation of capsular bag containing IOL and ring in pseudoexfoliation syndrome
- the use of Type 14 rings in pediatric patients – size issues and potential radial tears in capsular bag