Devices › Excimer laser system
Device brand name · Ophthalmic excimer laser system
WaveLight EX500 Excimer Laser: medical device reports filed with FDA
2,123 reports name it, 2011–2026. Manufacturer given most often on reports: Wavelight. Product code LZS.
- 2,123
- device reports naming the brand
- 0% of all MAUDE reports · about 139 a year
- 116
- reports, 12 months to August 2026
- 151 in the 12 months before
- 22.8%
- classified as malfunction
- 14% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 2,123 reports that name the brand "WaveLight EX500 Excimer Laser" (ophthalmic excimer laser system), received between April 2011 and August 2026; the manufacturer given most often on reports is Wavelight. Spellings of one product vary from report to report.
116 reports arrived in the 12 months to August 2026, down 23% from 151 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (77.2%) and malfunction (22.8%); across all excimer laser system reports (product code LZS) death is recorded in 0.1% and malfunction in 14%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (7.8%), device operates differently than expected (7%) and device displays incorrect message (5.5%). The patient problems coded most often are visual impairment, blurred vision and appropriate clinical signs, symptoms and conditions term/code not available. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 13,785 reports carrying product code LZS. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Insufficient device problem information | 166 | 7.8% | 13.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 148 | 7% | 4% |
| Device displays incorrect message | 117 | 5.5% | 2.9% |
| Overcorrection | 73 | 3.4% | 1.1% |
| Improper or incorrect procedure or method | 72 | 3.4% | 1.5% |
| Energy output problem | 49 | 2.3% | 1.1% |
| Unexpected therapeutic results | 45 | 2.1% | 1.1% |
| Device inoperablethe device could not be used | 42 | 2% | 0.5% |
| Gas/air leak | 40 | 1.9% | 0.6% |
| Inaccurate delivery | 26 | 1.2% | 0.2% |
| Failure to capture | 25 | 1.2% | 0.4% |
| Therapeutic or diagnostic output failure | 25 | 1.2% | 0.6% |
| Failure to align | 19 | 0.9% | 0.6% |
| Device emits odor | 15 | 0.7% | 0.3% |
| Output problem | 13 | 0.6% | 0.2% |
| Defective devicethe device was defective | 10 | 0.5% | 0.2% |
| Device sensing problem | 10 | 0.5% | 0.1% |
| Undercorrection | 10 | 0.5% | 0.1% |
| Incorrect interpretation of signal | 9 | 0.4% | 0.1% |
| Incorrect, inadequate or imprecise result or readings | 9 | 0.4% | 0.3% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Visual impairmentreduced vision | 346 | 16.3% |
| Blurred vision | 208 | 9.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 176 | 8.3% |
| Keratitis | 132 | 6.2% |
| Visual disturbances | 124 | 5.8% |
| Corneal clouding/hazing | 107 | 5% |
| Uveitis | 57 | 2.7% |
| Postoperative refraction, unexpected | 55 | 2.6% |
| Dry eye(s) | 53 | 2.5% |
| Therapeutic effects, unexpected | 51 | 2.4% |
| Overcorrection | 46 | 2.2% |
| Painpain, site not specified | 41 | 1.9% |
| Glaucomaraised pressure in the eye | 32 | 1.5% |
| Therapeutic response, decreased | 26 | 1.2% |
| Halo | 24 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | WaveLight EX500 Excimer Laser | Product code LZS | All MAUDE reports |
|---|---|---|---|
| Reports | 2,123 | 13,785 | 26,136,888 |
| Share of that pool | — | 15.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 77.2% | 84.6% | 36.2% |
| Classified as malfunction | 22.8% | 14% | 62.3% |
| Filed by the manufacturer | 99.5% | 87.7% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code LZS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Allegretto Wave Eye-Q Excimer Laser | 3,878 | 0 | 0% |
| Allegretto Wave Eye-Q | 2,979 | 0 | 0% |
| Lasik | 493 | 7 | 1.2% |
| Star | 520 | 50 | 0% |
| Ladarvision 4000 | 499 | 0 | 0% |
| Ladar6000 System | 321 | 0 | 0% |
| Allegretto Wave | 198 | 0 | 0% |
| S4-Ir-Etl | 191 | 0 | 0% |
| Visx Excimer Laser | 175 | 0 | 0% |
| WaveLight FS200 Femtosecond Laser | 4,653 | 486 | 0% |
| Concerto | 843 | 199 | 2.7% |
| Intralase Fs2 | 3,679 | 9 | 0% |
| Lensx Laser System | 2,632 | 119 | 0% |
| Alcon | 180 | 2 | 0% |
| Catalys System | 958 | 67 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about WaveLight EX500 Excimer Laser reports
How many FDA reports name WaveLight EX500 Excimer Laser?
2,123 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 116 in the latest 12 months.
What kinds of events are reported?
injury (77.2%) and malfunction (22.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (7.8%), device operates differently than expected (7%), device displays incorrect message (5.5%), overcorrection (3.4%) and improper or incorrect procedure or method (3.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that WaveLight EX500 Excimer Laser was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.