Excimer laser system: medical device reports filed with FDA

13,785 reports carry this product code, 1994–2026; 18 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

13,785
reports with this product code: 0.1% of all MAUDE reports; 163
reports, 12 months to August 2026: 231 in the 12 months before; 14%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code LZS is FDA's classification for "Excimer laser system" (unknown panel), a class 3 device. 13,785 medical device reports carry this product code, 0.1% of the MAUDE database, from August 1994 to August 2026.

163 reports arrived in the 12 months to August 2026, down 29% from 231 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 (84.6%), malfunction (14%) and other (0.9%). 18 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Allegretto Wave Eye-Q Excimer Laser	3,878	0	0%	8.4%
Allegretto Wave Eye-Q	2,972	0	0%	12.5%
WaveLight EX500 Excimer Laser	2,113	116	0%	22.8%
Lasik	474	7	1.2%	1.8%
Star	446	50	0%	9%
Ladarvision 4000	440	0	0%	30.1%
Ladar6000 System	319	0	0%	47.7%
Allegretto Wave	196	0	0%	31.3%
S4-Ir-Etl	188	0	0%	5.8%
Visx Excimer Laser	174	0	0%	0.6%
WaveLight FS200 Femtosecond Laser	118	486	0%	53.5%
Concerto	18	199	2.7%	62.8%
Intralase Fs2	5	9	0%	2%
Lensx Laser System	5	119	0%	40.8%
Alcon	3	2	0%	36.7%
Catalys System	3	67	0%	53%
Intralase	2	0	0%	90.2%
Intralase Fs Laser	1	0	0%	2.9%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Wavelight	9,032	65.5%
Abbott Medical Optics	677	4.9%
Amo Manufacturing USA	304	2.2%
Johnson & Johnson Surgical Vision	264	1.9%
Alcon Laboratories	27	0.2%
Bausch & Lomb Surgical	12	0.1%
Alcon Laboratories Ireland	5	0%
Animas	3	0%
Advanced Medical Optics	2	0%
Abbott	1	0%
Alcon Research / Huntington	1	0%
Bausch & Lomb	1	0%
Lumenis	1	0%
Staar Surgical	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.1%12

Injury84.6%11,665

Malfunction14%1,935

Other0.9%126

Not given0.3%47

Who filed

Manufacturer report87.7%12,093

Voluntary report12%1,652

User facility report0%0

Distributor report0%1

Not given0.3%39

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	1,852	13.4%
Device operates differently than expectedthe device behaved unexpectedly	551	4%
Device displays incorrect message	402	2.9%
Improper or incorrect procedure or method	206	1.5%
Patient-device incompatibilitythe device did not suit the patient	179	1.3%
Energy output problem	158	1.1%
Overcorrection	155	1.1%
Failure to fire	149	1.1%
Unexpected therapeutic results	145	1.1%
Computer software problema software problem	93	0.7%
Failure to align	85	0.6%
Therapeutic or diagnostic output failure	79	0.6%
Gas/air leak	78	0.6%
Device inoperablethe device could not be used	65	0.5%
Other (for use when an appropriate device code cannot be identified)	65	0.5%
Failure to capture	56	0.4%
Incorrect, inadequate or imprecise result or readings	43	0.3%
Unintended movement	41	0.3%
Device emits odor	38	0.3%
Output problem	32	0.2%

Questions about excimer laser system reports

What is product code LZS?

FDA's classification code for "Excimer laser system", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

13,785 reports through August 2026, 163 of them in the latest 12 months.

Which brands appear most often?

Allegretto Wave Eye-Q Excimer Laser (3,878), Allegretto Wave Eye-Q (2,972), WaveLight EX500 Excimer Laser (2,113), Lasik (474) and Star (446). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.