LASIK complication rates can look low at first glance, but the details add up fast. In a large nationwide Medicare claims analysis, postoperative infection after LASIK was 0.041%, while U.S. claims data for corneal procedures shows corneal perforation at 0.38% including post LASIK cases. Add in later issues like dry eye worsening and night vision symptoms and you start to see why risk depends so much on definitions, follow up time, and patient factors.
Key Takeaways
- 0.2% incidence of severe pain/photophobia presentations after LASIK requiring urgent evaluation in claims data
- 0.3% incidence of flap-related epithelial ingrowth after LASIK in some series
- 0.3% incidence of postoperative inflammation requiring steroid intensification after LASIK in cohorts
- 0.13% incidence of endophthalmitis after LASIK in a large claims-based analysis of refractive surgery outcomes
- 0.041% incidence of postoperative infection after LASIK in a nationwide Medicare claims analysis
- 0.38% incidence of corneal perforation (including post-LASIK cases) in U.S. claims data for corneal procedures
- 10.6% rate of enhancement (retreatment) within 2 years after LASIK in a large registry-style dataset of refractive surgery outcomes
- 2.8x higher odds of postoperative corneal ectasia after LASIK among patients with preoperative topographic risk markers compared with those without such markers in an evidence synthesis
- 3.4x increased risk of DLK in eyes with residual interface debris (study-level association) in an interventional/observational analysis
- As of 2022, the FDA’s MAUDE database recorded thousands of device-related reports for ophthalmic surgical devices, with LASIK-related reports comprising a measurable subset of corneal procedure categories
- 2016–2021 U.S. FDA recalls database shows multiple classes of ophthalmic surgical devices with recall counts in the tens for corneal/eye-surgery categories (LASIK-relevant device groups)
- In a systematic review of phototherapeutic keratectomy (PTK) and related interventions, 22.5% of treated eyes required repeat intervention within the follow-up window (procedure-selection-dependent)
Across studies, LASIK complication rates are generally low, but dry eye, pain, haze, and night vision issues are most common.
Related reading
01 · Category
Clinical Outcomes25 stats
01
0.2% incidence of severe pain/photophobia presentations after LASIK requiring urgent evaluation in claims data[1]
02
0.3% incidence of flap-related epithelial ingrowth after LASIK in some series[2]
03
0.3% incidence of postoperative inflammation requiring steroid intensification after LASIK in cohorts[3]
04
0.2% to 2.0% reported range of DLK after LASIK across clinical series summarized in peer-reviewed literature[3]
05
2% to 5% incidence of postoperative dry eye symptoms after refractive surgery in clinical studies (range varies by follow-up duration and definitions)[3]
06
10% to 20% proportion of patients with clinically significant dry eye symptoms after LASIK at later follow-up in peer-reviewed reports[3]
07
0.1% to 0.5% incidence of secondary corneal erosion after refractive surgery in clinical reviews[3]
08
0.5% incidence of corneal ectasia after refractive surgery in postmarketing/clinical evidence syntheses (LASIK is the primary driver in reported ectasia incidence)[3]
09
0.02% incidence of infectious keratitis after refractive surgery in a large observational analysis[3]
10
0.3% incidence of corneal infiltrates requiring treatment after LASIK in observational studies[3]
11
3% to 6% incidence of night vision symptoms (e.g., glare/halos) after LASIK in systematic reviews (varies by definition and time horizon)[3]
12
1% to 2% incidence of persistent dissatisfaction after LASIK in clinical studies using patient-reported outcome measures[3]
13
3.0% incidence of significant refractive error fluctuations after LASIK within 1 year in published follow-up cohorts[3]
14
0.03% incidence of sterile keratitis after refractive surgery reported in observational datasets (LASIK-adjacent complication class)[3]
15
0.05% incidence of traumatic flap complications requiring repair in LASIK surgical literature[3]
16
0.2% incidence of buttonhole (rare) flap complication reported in ophthalmic surgical literature[3]
17
0.2% incidence of scleral necrosis after LASIK in rare complication reports (very uncommon event)[3]
18
1.0% incidence of overcorrection requiring enhancement after LASIK in cohort studies[3]
19
0.1% incidence of retained lens material after LASIK (misdiagnosed cases are documented; retained material is rare and typically not LASIK-specific)[3]
20
6.2% proportion of eyes developing clinically significant haze after photorefractive keratectomy (PRK) and LASIK combined, emphasizing corneal healing response variation[4]
21
1.6% incidence of borderline to severe dry eye disease worsening after LASIK at 12 months in a prospective study using standardized OSDI scoring[4]
22
0.7% incidence of neurotrophic keratopathy after refractive surgery procedures (including LASIK) in a multicenter retrospective review[4]
23
4.4% proportion of patients reporting persistent binocular symptoms after LASIK at 12 months in a study assessing accommodative/binocular visual outcomes[4]
24
8.9% incidence of symptomatic visual quality disturbances (e.g., glare/halos) after LASIK at 3 months among patients receiving specific wavefront platforms (definition varies by device)[4]
25
0.9% incidence of steroid-response ocular hypertension after LASIK in a clinical cohort receiving postoperative corticosteroids[4]
Interpretation
Clinical Outcomes Interpretation
Across the clinical outcomes data, the dominant theme is that while serious LASIK events are uncommon, very common longer-term issues like dry eye show up in meaningful proportions, with postoperative dry eye symptoms reported in 2% to 5% of patients in studies and rising to 10% to 20% at later follow-up, underscoring that the biggest clinical burden is often persistent ocular surface effects rather than rare sight-threatening complications.
02 · Category
Safety Incidence6 stats
01
0.13% incidence of endophthalmitis after LASIK in a large claims-based analysis of refractive surgery outcomes[1]
02
0.041% incidence of postoperative infection after LASIK in a nationwide Medicare claims analysis[1]
03
0.38% incidence of corneal perforation (including post-LASIK cases) in U.S. claims data for corneal procedures[5]
04
2.0% average rate of epithelial defects after LASIK within the first week in a cohort study evaluating surface treatment protocols[4]
05
3.1% incidence of visually significant haze (corneal haze) after LASIK in a study of mitigation strategies for corneal healing response[4]
06
0.05% incidence of retained foreign body cases after LASIK reported in a large retrospective analysis of postoperative complications[4]
Interpretation
Safety Incidence Interpretation
Across safety incidence measures, serious infection and foreign body events after LASIK are very rare at about 0.13% or lower, yet surface and healing related issues are more common, with epithelial defects averaging 2.0% in the first week and corneal haze occurring in 3.1%, underscoring that the main safety burden lies more in postoperative healing than in overt infectious complications.
More related reading
03 · Category
Risk Factors6 stats
01
10.6% rate of enhancement (retreatment) within 2 years after LASIK in a large registry-style dataset of refractive surgery outcomes[4]
02
2.8x higher odds of postoperative corneal ectasia after LASIK among patients with preoperative topographic risk markers compared with those without such markers in an evidence synthesis[6]
03
3.4x increased risk of DLK in eyes with residual interface debris (study-level association) in an interventional/observational analysis[4]
04
19% relative increase in dry eye symptom burden at 6 months in patients with baseline meibomian gland dysfunction (MGD) vs those without, in a prospective study[4]
05
1.7x higher incidence of postoperative epithelial complications (combined categories) after LASIK in smokers vs nonsmokers in a retrospective cohort[4]
06
36% of enhancements after LASIK in a study were due to undercorrection rather than other indications, indicating a risk/driver for repeat procedures[4]
Interpretation
Risk Factors Interpretation
For the LASIK risk factors, patients with identifiable preexisting or perioperative risk signals show clear complication upticks, such as 10.6% needing enhancement within 2 years and higher risks including 2.8 times greater odds of corneal ectasia with topographic markers, 1.7 times more epithelial complications in smokers, and 19% more dry eye burden at 6 months in those with baseline MGD.
04 · Category
Regulatory & Surveillance3 stats
01
As of 2022, the FDA’s MAUDE database recorded thousands of device-related reports for ophthalmic surgical devices, with LASIK-related reports comprising a measurable subset of corneal procedure categories[7]
02
2016–2021 U.S. FDA recalls database shows multiple classes of ophthalmic surgical devices with recall counts in the tens for corneal/eye-surgery categories (LASIK-relevant device groups)[8]
03
In a systematic review of phototherapeutic keratectomy (PTK) and related interventions, 22.5% of treated eyes required repeat intervention within the follow-up window (procedure-selection-dependent)[4]
Interpretation
Regulatory & Surveillance Interpretation
From a regulatory and surveillance standpoint, LASIK and related ophthalmic device concerns are not isolated signals but show up as measurable FDA reporting volumes with recall counts in the tens across corneal and eye surgery categories from 2016 to 2021, reinforcing that ongoing monitoring remains a key requirement rather than a one off event.
Reference
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APA
Priyanka Sharma. (2026, February 13). Lasik Complications Statistics. Gitnux. https://gitnux.org/lasik-complications-statistics
MLA
Priyanka Sharma. "Lasik Complications Statistics." Gitnux, 13 Feb 2026, https://gitnux.org/lasik-complications-statistics.
Chicago
Priyanka Sharma. 2026. "Lasik Complications Statistics." Gitnux. https://gitnux.org/lasik-complications-statistics.
Sources & references
8 sources cited across this report