Draft Panel Questions
LASIK Post Market Experience:
- Please
discuss any recommendations you may have for modifications to patient
labeling of excimer lasers for LASIK.
- Please
discuss any recommendations you may have for modifications to FDA’s LASIK
website.
- 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.
- 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:
- Please
discuss any recommendations you may have for modifications to patient
labeling of phakic intraocular lenses (PIOLs).
- Please
discuss any recommendations you may have for modifications to FDA’s PIOL website.
- Please
discuss any recommendations you may have for future revisions of the ANSI
and ISO PIOL standards.
- The
training manual for SightNet participants currently emphasizes evaluation
for and reporting of the following PIOL-related adverse events and complications:
- Toxic
anterior segment syndrome (TASS)
- Endophthalmitis
- Explants
- Significant
endothelial cell density (ECD) losses
- Corneal
decompensation
- Significant
losses of best corrected visual acuity (BCVA)
- Retinal
detachments
- Intraocular
pressure (IOP) spikes/elevations
- Cataractogenesis
- Device
extrusions
- Device
failures/damage.
Please discuss any
recommendations you may have for revision of this list of adverse events and
complications for which reporting is emphasized.