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Device brand name · Powered laser surgical instrument
WaveLight FS200 Femtosecond Laser: medical device reports filed with FDA
4,653 reports name it, 2011–2026. Manufacturer given most often on reports: Wavelight. Product code GEX.
- 4,653
- device reports naming the brand
- 0% of all MAUDE reports · about 305 a year
- 486
- reports, 12 months to August 2026
- 287 in the 12 months before
- 53.5%
- classified as malfunction
- 78.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
4,653 medical device reports received by FDA name the brand "WaveLight FS200 Femtosecond Laser" (powered laser surgical instrument); the manufacturer given most often on reports is Wavelight; received from April 2011 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
486 reports arrived in the 12 months to August 2026, up 69% from 287 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 malfunction (53.5%) and injury (46.5%); across all powered laser surgical instrument reports (product code GEX) death is recorded in 0.2% and malfunction in 78.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to align (11.9%), device operates differently than expected (11.9%) and suction problem (8.8%). The patient problems coded most often are keratitis, appropriate clinical signs, symptoms and conditions term/code not available and visual disturbances. 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 44,283 reports carrying product code GEX. 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 |
|---|---|---|---|
| Failure to align | 555 | 11.9% | 2.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 554 | 11.9% | 3.6% |
| Suction problem | 410 | 8.8% | 1.1% |
| Unexpected therapeutic results | 348 | 7.5% | 1.1% |
| Insufficient device problem information | 343 | 7.4% | 2.7% |
| Decrease in suction | 204 | 4.4% | 3.5% |
| Failure to cut | 196 | 4.2% | 0.4% |
| Device displays incorrect message | 77 | 1.7% | 3.4% |
| Breakthe device broke | 57 | 1.2% | 18.9% |
| Suction failure | 52 | 1.1% | 0.2% |
| Therapeutic or diagnostic output failure | 47 | 1% | 1.1% |
| Inadequacy of device shape and/or size | 40 | 0.9% | 0.1% |
| Gas/air leak | 35 | 0.8% | 0.1% |
| Computer software problema software problem | 31 | 0.7% | 0.4% |
| Defective devicethe device was defective | 24 | 0.5% | 2.1% |
| Output problem | 19 | 0.4% | 1.7% |
| Improper or incorrect procedure or method | 18 | 0.4% | 0.5% |
| Air leak | 17 | 0.4% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 16 | 0.3% | 0.1% |
| Pressure problem | 16 | 0.3% | 0% |
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 |
|---|---|---|
| Keratitis | 892 | 19.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 284 | 6.1% |
| Visual disturbances | 182 | 3.9% |
| Visual impairmentreduced vision | 159 | 3.4% |
| Tissue damage | 75 | 1.6% |
| Blurred vision | 73 | 1.6% |
| Corneal clouding/hazing | 59 | 1.3% |
| Eye injury | 50 | 1.1% |
| Complaint, ill-defined | 48 | 1% |
| Corneal perforation | 39 | 0.8% |
| Dry eye(s) | 29 | 0.6% |
| Corneal abrasion | 26 | 0.6% |
| Halo | 26 | 0.6% |
| Painpain, site not specified | 26 | 0.6% |
| Corneal edema | 25 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | WaveLight FS200 Femtosecond Laser | Product code GEX | All MAUDE reports |
|---|---|---|---|
| Reports | 4,653 | 44,283 | 26,136,888 |
| Share of that pool | — | 10.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 46.5% | 20% | 36.2% |
| Classified as malfunction | 53.5% | 78.1% | 62.3% |
| Filed by the manufacturer | 99.3% | 94.9% | 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 GEX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Greenlight Moxy Fiber Optic | 9,059 | 0 | 0% |
| Greenlight Addstat | 3,389 | 0 | 0% |
| FS Disposable Interface | 1,442 | 116 | 0% |
| Greenlight Hps Bph Fiber Optic | 906 | 0 | 0% |
| Flexiva Tm Tractip High Power Single-Use Laser Fiber | 627 | 0 | 0% |
| Greenlight Xps Laser System | 622 | 0 | 0.2% |
| Lumenis Moses 200 D\F\L | 582 | 227 | 0% |
| Flexiva Tm High Power Single-Use Laser Fiber | 565 | 0 | 0.2% |
| Visualase | 595 | 48 | 0.8% |
| Neuroblate System | 553 | 12 | 4% |
| SOLTIVE Premium SuperPulsed Laser System | 522 | 117 | 0% |
| Moxy | 511 | 276 | 0% |
| Moses Pulse | 477 | 143 | 0% |
| Angled Delivery Device Greenlight | 465 | 0 | 0% |
| SlimLine SIS EZ | 465 | 139 | 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 FS200 Femtosecond Laser reports
How many FDA reports name WaveLight FS200 Femtosecond Laser?
4,653 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 486 in the latest 12 months.
What kinds of events are reported?
malfunction (53.5%) and injury (46.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to align (11.9%), device operates differently than expected (11.9%), suction problem (8.8%), unexpected therapeutic results (7.5%) and insufficient device problem information (7.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that WaveLight FS200 Femtosecond 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.