Devices › Excimer laser system
Device brand name · Ophthalmic excimer laser system
Allegretto Wave: medical device reports filed with FDA
198 reports name it, 2009–2014. Manufacturer given most often on reports: Wavelight. Product code LZS.
- 198
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 31.3%
- classified as malfunction
- 14% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
198 medical device reports received by FDA name the brand "Allegretto Wave" (ophthalmic excimer laser system); the manufacturer given most often on reports is Wavelight; received from November 2009 to December 2014. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (66.2%), malfunction (31.3%) and other (2.5%); 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 (13.6%), device displays incorrect message (10.1%) and computer software problem (8.1%). The patient problems coded most often are overcorrection, blurred vision and visual impairment. 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
No report naming Allegretto Wave was received in the five years to August 2026; the latest was received in December 2014.
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 | 27 | 13.6% | 13.4% |
| Device displays incorrect message | 20 | 10.1% | 2.9% |
| Computer software problema software problem | 16 | 8.1% | 0.7% |
| Failure to fire | 10 | 5.1% | 1.1% |
| Energy output problem | 7 | 3.5% | 1.1% |
| Image display error/artifact | 3 | 1.5% | 0% |
| Intermittent continuity | 3 | 1.5% | 0.1% |
| Ambient noise problem | 2 | 1% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 1% | 4% |
| Failure to align | 2 | 1% | 0.6% |
| Inaccurate delivery | 2 | 1% | 0.2% |
| No display/image | 2 | 1% | 0.1% |
| Burst container or vessel | 1 | 0.5% | 0% |
| Calibration error | 1 | 0.5% | 0% |
| Calibration problem | 1 | 0.5% | 0.2% |
| Device emits odor | 1 | 0.5% | 0.3% |
| Device inoperablethe device could not be used | 1 | 0.5% | 0.5% |
| Device operational issue | 1 | 0.5% | 0.1% |
| Failure to advance | 1 | 0.5% | 0% |
| Failure to deliver energy | 1 | 0.5% | 0.1% |
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 |
|---|---|---|
| Overcorrection | 64 | 32.3% |
| Blurred vision | 39 | 19.7% |
| Visual impairmentreduced vision | 16 | 8.1% |
| No patient involvement | 15 | 7.6% |
| Postoperative refraction, unexpected | 11 | 5.6% |
| Visual disturbances | 10 | 5.1% |
| Keratitis | 5 | 2.5% |
| Dry eye(s) | 4 | 2% |
| Halo | 4 | 2% |
| Increased sensitivity | 4 | 2% |
| Corneal infiltrates | 3 | 1.5% |
| Wrinkling | 3 | 1.5% |
| Corneal ulcer | 2 | 1% |
| Depressionlow mood | 2 | 1% |
| Diplopiadouble vision | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Allegretto Wave | Product code LZS | All MAUDE reports |
|---|---|---|---|
| Reports | 198 | 13,785 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 66.2% | 84.6% | 36.2% |
| Classified as malfunction | 31.3% | 14% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| WaveLight EX500 Excimer Laser | 2,123 | 116 | 0% |
| Lasik | 493 | 7 | 1.2% |
| Star | 520 | 50 | 0% |
| Ladarvision 4000 | 499 | 0 | 0% |
| Ladar6000 System | 321 | 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 Allegretto Wave reports
How many FDA reports name Allegretto Wave?
198 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (66.2%), malfunction (31.3%) and other (2.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (13.6%), device displays incorrect message (10.1%), computer software problem (8.1%), failure to fire (5.1%) and energy output problem (3.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Allegretto Wave 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.