Corneal lenticule

SMILE issue evidence

These groups describe the coverage of this database—not a ranking of severity or a personal risk estimate.

Cohort evidence
5
Community only
1
Current gaps
5
Absence is never treated as a zero rate. Only imported cohort observations receive numeric summaries. Community counts indicate an issue-specific structured mention, not necessarily a new, severe or ongoing problem.

Observed in current cohorts

Source-linked study data. Each number stays attached to its cohort, denominator and follow-up period.

5

Dry eye and ocular-surface symptoms

New or worsened dryness, irritation or tear-film disturbance reported or measured after the procedure. Questionnaires, tests and thresholds are not interchangeable.

FDA recognition source ↗
20 cohort observations6 community reports

Loss of best-corrected vision

A reduction in chart lines even with the best glasses or contact-lens correction available after surgery.

FDA recognition source ↗
0%–16.0% · 7 observations

Structured community mentions only

An anecdotal layer kept separate from clinical evidence; these counts are not incidence estimates.

1

Starbursts

Rays or streaks around point light sources, usually assessed through a patient questionnaire rather than a single universal test.

FDA recognition source ↗
1 community report · no cohort observation
No structured cohort observation is currently imported.

1 approved public-forum report contains an issue-specific structured mention. This is not an incidence estimate.

Browse SMILE community reports →

Recognised issues without a current observation

Coverage gaps remain visible because missing data must not be mistaken for zero events.

5

Diffuse lamellar keratitis (DLK)

Sterile inflammation in the corneal interface after a lamellar procedure. Severity and treatment requirements vary.

FDA recognition source ↗
No current cohort observation

Epithelial ingrowth or trapped epithelial cells

Surface epithelial cells located within a surgically created corneal interface; some cases are observed while others may require treatment.

FDA recognition source ↗
No current cohort observation

Infectious keratitis / corneal infection

A postoperative infection of the cornea. It is distinct from endophthalmitis, which involves the inside of the eye.

FDA recognition source ↗
No current cohort observation

Residual error, regression or additional correction

Under-correction, over-correction, regression or another refractive result that may leave a need for glasses, contact lenses or an additional procedure.

FDA recognition source ↗
No current cohort observation

Retained cells or debris in the SMILE interface

Cells, tissue or debris trapped in the corneal space where the lenticule was removed, with effects ranging from none to corneal irregularity and blurred vision.

FDA recognition source ↗
No current cohort observation