Devices › Excimer laser system
Device brand name · Excimer laser
Visx Excimer Laser: medical device reports filed with FDA
175 reports name it, 2008–2012. Manufacturer given most often on reports: Amo Manufacturing USA. Product code LZS.
- 175
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0.6%
- 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 175 reports that name the brand "Visx Excimer Laser" (excimer laser), received between June 2008 and May 2012; the manufacturer given most often on reports is Amo Manufacturing USA. Spellings of one product vary from report to report.
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 (98.9%), malfunction (0.6%) and other (0.6%); 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 (48%), optical obstruction (8%) and overcorrection (7.4%). The patient problems coded most often are visual impairment, dry eye(s) 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
No report naming Visx Excimer Laser was received in the five years to August 2026; the latest was received in May 2012.
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 | 84 | 48% | 13.4% |
| Optical obstruction | 14 | 8% | 0.1% |
| Overcorrection | 13 | 7.4% | 1.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 4% | 4% |
| Improper or incorrect procedure or method | 6 | 3.4% | 1.5% |
| Energy output problem | 2 | 1.1% | 1.1% |
| Normal | 2 | 1.1% | 0.1% |
| Calibration problem | 1 | 0.6% | 0.2% |
| Computer software problema software problem | 1 | 0.6% | 0.7% |
| Device inoperablethe device could not be used | 1 | 0.6% | 0.5% |
| Entrapment of device | 1 | 0.6% | 0% |
| Gas/air leak | 1 | 0.6% | 0.6% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.6% | 1.3% |
| Programming issue | 1 | 0.6% | 0% |
| Therapy delivered to incorrect body area | 1 | 0.6% | 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 |
|---|---|---|
| Visual impairmentreduced vision | 75 | 42.9% |
| Dry eye(s) | 16 | 9.1% |
| Visual disturbances | 15 | 8.6% |
| Keratitis | 14 | 8% |
| Overcorrection | 13 | 7.4% |
| Loss of vision | 6 | 3.4% |
| Blurred vision | 5 | 2.9% |
| Other (for use when an appropriate patient code cannot be identified) | 5 | 2.9% |
| Corneal infiltrates | 4 | 2.3% |
| Halo | 4 | 2.3% |
| Headachehead pain | 2 | 1.1% |
| Inflammationinflammation | 2 | 1.1% |
| Surgical procedure, additional | 2 | 1.1% |
| Bone fracture(s) | 1 | 0.6% |
| Cataractclouding of the eye lens | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Visx Excimer Laser | Product code LZS | All MAUDE reports |
|---|---|---|---|
| Reports | 175 | 13,785 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 98.9% | 84.6% | 36.2% |
| Classified as malfunction | 0.6% | 14% | 62.3% |
| Filed by the manufacturer | 99.4% | 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% |
| Allegretto Wave | 198 | 0 | 0% |
| S4-Ir-Etl | 191 | 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 Visx Excimer Laser reports
How many FDA reports name Visx Excimer Laser?
175 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 (98.9%), malfunction (0.6%) and other (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (48%), optical obstruction (8%), overcorrection (7.4%), device operates differently than expected (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 (99.4%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Visx 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.