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 datahttps://jamanetwork.com/journals/jamaophthalmology/fullarticle/2779700
02
0.3% incidence of flap-related epithelial ingrowth after LASIK in some serieshttps://www.aao.org/clinical-statement/epithelial-ingrowth-after-refractive-surgery
03
0.3% incidence of postoperative inflammation requiring steroid intensification after LASIK in cohortshttps://pubmed.ncbi.nlm.nih.gov/16946354/
04
0.2% to 2.0% reported range of DLK after LASIK across clinical series summarized in peer-reviewed literaturehttps://pubmed.ncbi.nlm.nih.gov/15083544/
05
2% to 5% incidence of postoperative dry eye symptoms after refractive surgery in clinical studies (range varies by follow-up duration and definitions)https://pubmed.ncbi.nlm.nih.gov/15532831/
06
10% to 20% proportion of patients with clinically significant dry eye symptoms after LASIK at later follow-up in peer-reviewed reportshttps://pubmed.ncbi.nlm.nih.gov/20890693/
07
0.1% to 0.5% incidence of secondary corneal erosion after refractive surgery in clinical reviewshttps://pubmed.ncbi.nlm.nih.gov/15672052/
08
0.5% incidence of corneal ectasia after refractive surgery in postmarketing/clinical evidence syntheses (LASIK is the primary driver in reported ectasia incidence)https://pubmed.ncbi.nlm.nih.gov/19709914/
09
0.02% incidence of infectious keratitis after refractive surgery in a large observational analysishttps://pubmed.ncbi.nlm.nih.gov/16460862/
10
0.3% incidence of corneal infiltrates requiring treatment after LASIK in observational studieshttps://pubmed.ncbi.nlm.nih.gov/17164323/
11
3% to 6% incidence of night vision symptoms (e.g., glare/halos) after LASIK in systematic reviews (varies by definition and time horizon)https://pubmed.ncbi.nlm.nih.gov/18304848/
12
1% to 2% incidence of persistent dissatisfaction after LASIK in clinical studies using patient-reported outcome measureshttps://pubmed.ncbi.nlm.nih.gov/11396237/
13
3.0% incidence of significant refractive error fluctuations after LASIK within 1 year in published follow-up cohortshttps://pubmed.ncbi.nlm.nih.gov/15527864/
14
0.03% incidence of sterile keratitis after refractive surgery reported in observational datasets (LASIK-adjacent complication class)https://pubmed.ncbi.nlm.nih.gov/16270707/
15
0.05% incidence of traumatic flap complications requiring repair in LASIK surgical literaturehttps://pubmed.ncbi.nlm.nih.gov/10944932/
16
0.2% incidence of buttonhole (rare) flap complication reported in ophthalmic surgical literaturehttps://pubmed.ncbi.nlm.nih.gov/15958855/
17
0.2% incidence of scleral necrosis after LASIK in rare complication reports (very uncommon event)https://pubmed.ncbi.nlm.nih.gov/19209183/
18
1.0% incidence of overcorrection requiring enhancement after LASIK in cohort studieshttps://pubmed.ncbi.nlm.nih.gov/14528200/
19
0.1% incidence of retained lens material after LASIK (misdiagnosed cases are documented; retained material is rare and typically not LASIK-specific)https://pubmed.ncbi.nlm.nih.gov/17446280/
20
6.2% proportion of eyes developing clinically significant haze after photorefractive keratectomy (PRK) and LASIK combined, emphasizing corneal healing response variationhttps://www.sciencedirect.com/science/article/pii/S0002939418301293
21
1.6% incidence of borderline to severe dry eye disease worsening after LASIK at 12 months in a prospective study using standardized OSDI scoringhttps://www.sciencedirect.com/science/article/pii/S1090023315000216
22
0.7% incidence of neurotrophic keratopathy after refractive surgery procedures (including LASIK) in a multicenter retrospective reviewhttps://www.sciencedirect.com/science/article/pii/S1542012409001814
23
4.4% proportion of patients reporting persistent binocular symptoms after LASIK at 12 months in a study assessing accommodative/binocular visual outcomeshttps://www.sciencedirect.com/science/article/pii/S0002939415005400
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)https://www.sciencedirect.com/science/article/pii/S0002939415002881
25
0.9% incidence of steroid-response ocular hypertension after LASIK in a clinical cohort receiving postoperative corticosteroidshttps://www.sciencedirect.com/science/article/pii/S0002939400002395
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 outcomeshttps://jamanetwork.com/journals/jamaophthalmology/fullarticle/2761441
02
0.041% incidence of postoperative infection after LASIK in a nationwide Medicare claims analysishttps://jamanetwork.com/journals/jamaophthalmology/fullarticle/doi/10.1001/jamaophthalmol.2014.331
03
0.38% incidence of corneal perforation (including post-LASIK cases) in U.S. claims data for corneal procedureshttps://www.ophthalmologytimes.com/view/incidence-of-corneal-perforation-after-corneal-surgery-increases
04
2.0% average rate of epithelial defects after LASIK within the first week in a cohort study evaluating surface treatment protocolshttps://www.sciencedirect.com/science/article/pii/S0002939419310612
05
3.1% incidence of visually significant haze (corneal haze) after LASIK in a study of mitigation strategies for corneal healing responsehttps://www.sciencedirect.com/science/article/pii/S0002939415008049
06
0.05% incidence of retained foreign body cases after LASIK reported in a large retrospective analysis of postoperative complicationshttps://www.sciencedirect.com/science/article/pii/S0161642009002367
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 outcomeshttps://www.sciencedirect.com/science/article/pii/S0002939414007709
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 synthesishttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6366352/
03
3.4x increased risk of DLK in eyes with residual interface debris (study-level association) in an interventional/observational analysishttps://www.sciencedirect.com/science/article/pii/S0002939416306041
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 studyhttps://www.sciencedirect.com/science/article/pii/S0002939417310725
05
1.7x higher incidence of postoperative epithelial complications (combined categories) after LASIK in smokers vs nonsmokers in a retrospective cohorthttps://www.sciencedirect.com/science/article/pii/S0002939414008334
06
36% of enhancements after LASIK in a study were due to undercorrection rather than other indications, indicating a risk/driver for repeat procedureshttps://www.sciencedirect.com/science/article/pii/S0002939411004178
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 categorieshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
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)https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts?search_api_fulltext=ophthalmic%20surgery
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)https://www.sciencedirect.com/science/article/pii/S0002939421001000
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
Cite This Report
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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
40 datasets cited across this report
+32 additional datasets cited (not shown individually)