QUESTIONNAIRE FOR POST-MARKET SURVEILLANCE

In order to meet the requirements of the European MDR medical device regulation EU 2017/745, which stipulates that for each medical device, the clinical evaluation and its documentation must be followed by clinical data obtained through post-market surveillance.
We thank you for completing this electronic form concerning the use of the instruments provided by the company FIMCO.

INSTRUMENT INFORMATION
Below is the list of the type of instruments used:

INFORMATION CONCERNING INDICATIONS
Below is the list of processed indications:

CASE NUMBER INFORMATION
Complete the number of cases by indication or by default the total number of cases:
Indications Number of cases
Strabismus surgery
Glaucoma
Pterygium
Cataract
DCR
Retina
Other (specify)
Other (specify)
Total*


INFORMATION CONCERNING THE USE OF INSTRUMENTS DURING SURGERY
Have you encountered any complications while using the instruments?
If yes, indicate which ones:
INFORMATION ABOUT COMPLICATIONS
In how many cases have you had complications with the instruments?
Specify type and cause: How many cases? And what percentage?
Did the instruments cause any adverse effects?
If yes, specify:
INSTRUMENT TRACKING INFORMATION
Did the device meet your expectations?
In your experience, is the product performing?
Based on your experience, is the product safe?
DO YOU HAVE ANY SUGGESTIONS FOR IMPROVING INSTRUMENT DESIGN TO INCREASE INSTRUMENT PERFORMANCE AND SAFETY?
Comments and suggestions: