Devices › Excimer laser system
Device brand name · Ophthalmic excimer laser system
Ladarvision 4000: medical device reports filed with FDA
499 reports name it, 2004–2008. Manufacturer given most often on reports: Alcon - Orlando Technology Center. Product code LZS.
- 499
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 30.1%
- classified as malfunction
- 14% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
499 medical device reports received by FDA name the brand "Ladarvision 4000" (ophthalmic excimer laser system); the manufacturer given most often on reports is Alcon - Orlando Technology Center; received from February 2004 to August 2008. 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 (69.1%), malfunction (30.1%) and other (0.4%); 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 failure to fire (17%), malfunction (3.6%) and other (for use when an appropriate device code cannot be identified) (3.2%). The patient problems coded most often are decreased bcva (best corrected visual acuity), visual impairment and overcorrection. 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 Ladarvision 4000 was received in the five years to August 2026; the latest was received in August 2008.
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 |
|---|---|---|---|
| Failure to fire | 85 | 17% | 1.1% |
| Malfunction | 18 | 3.6% | 0.2% |
| Other (for use when an appropriate device code cannot be identified) | 16 | 3.2% | 0.5% |
| Leak/splashthe device leaked | 8 | 1.6% | 0.2% |
| Device displays incorrect message | 7 | 1.4% | 2.9% |
| Device issuea problem with the device | 5 | 1% | 0.1% |
| Device emits odor | 4 | 0.8% | 0.3% |
| Energy output problem | 3 | 0.6% | 1.1% |
| Improper or incorrect procedure or method | 3 | 0.6% | 1.5% |
| Replace | 3 | 0.6% | 0% |
| Air leak | 2 | 0.4% | 0% |
| Decrease in pressure | 2 | 0.4% | 0% |
| Defective devicethe device was defective | 2 | 0.4% | 0.2% |
| Shutter failure | 2 | 0.4% | 0% |
| Calibration error | 1 | 0.2% | 0% |
| Component falling | 1 | 0.2% | 0% |
| Computer hardware error | 1 | 0.2% | 0% |
| Difficult to position | 1 | 0.2% | 0% |
| Metal shedding debris | 1 | 0.2% | 0% |
| Output, high | 1 | 0.2% | 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 |
|---|---|---|
| Decreased bcva (best corrected visual acuity) | 105 | 21% |
| Visual impairmentreduced vision | 68 | 13.6% |
| Overcorrection | 43 | 8.6% |
| Visual disturbances | 32 | 6.4% |
| Surgical procedure aborted/stopped | 27 | 5.4% |
| Blurred vision | 14 | 2.8% |
| Inflammationinflammation | 14 | 2.8% |
| Other (for use when an appropriate patient code cannot be identified) | 12 | 2.4% |
| Dry eye(s) | 9 | 1.8% |
| Infiltrates | 7 | 1.4% |
| Surgical procedure, repeated | 7 | 1.4% |
| Surgical procedure, additional | 6 | 1.2% |
| Surgical procedure | 5 | 1% |
| Therapeutic response, decreased | 5 | 1% |
| Corneal clouding/hazing | 4 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ladarvision 4000 | Product code LZS | All MAUDE reports |
|---|---|---|---|
| Reports | 499 | 13,785 | 26,136,888 |
| Share of that pool | — | 3.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 69.1% | 84.6% | 36.2% |
| Classified as malfunction | 30.1% | 14% | 62.3% |
| Filed by the manufacturer | 99.8% | 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% |
| 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 Ladarvision 4000 reports
How many FDA reports name Ladarvision 4000?
499 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 (69.1%), malfunction (30.1%) and other (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to fire (17%), malfunction (3.6%), other (for use when an appropriate device code cannot be identified) (3.2%), leak/splash (1.6%) and device displays incorrect message (1.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ladarvision 4000 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.