Draft Panel Questions

 

LASIK Post Market Experience:

 

  1. Please discuss any recommendations you may have for modifications to patient labeling of excimer lasers for LASIK.

 

  1. Please discuss any recommendations you may have for modifications to FDAs LASIK website.

 

  1. FDA is currently evaluating the ANSI Z80.11 Laser Systems for Corneal Reshaping Standard for recognition. Please discuss whether you recommend that the FDA recognize the standard in its entirety, in part, or with specific additions.

 

  1. The training manual for SightNet participants currently emphasizes evaluation for and reporting of the following LASIK-related adverse events and complications:

 

         Infectious keratitis

         Endemic cases of diffuse lamellar keratitis (DLK)

         Abnormal trends in postoperative topography

         Significant losses of best corrected visual acuity (BCVA)

         Glare, halos, starbursts, distortions

         Device failures.

 

Please discuss any recommendations you may have for revision of this list of adverse events and complications for which reporting is emphasized.

 

PIOL Post Market Experience:

 

  1. Please discuss any recommendations you may have for modifications to patient labeling of phakic intraocular lenses (PIOLs).

 

  1. Please discuss any recommendations you may have for modifications to FDAs PIOL website.

 

  1. Please discuss any recommendations you may have for future revisions of the ANSI and ISO PIOL standards.

 

  1. The training manual for SightNet participants currently emphasizes evaluation for and reporting of the following PIOL-related adverse events and complications:

 

 

Please discuss any recommendations you may have for revision of this list of adverse events and complications for which reporting is emphasized.