Device brand name · Excimer laser

S4-Ir-Etl: medical device reports filed with FDA

191 reports name it, 2013–2020. Manufacturer given most often on reports: Abbott Medical Optics. Product code LZS.

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.

191
device reports naming the brand: 0% of all MAUDE reports · about 15 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 5.8%
classified as malfunction: 14% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

191 medical device reports received by FDA name the brand "S4-Ir-Etl" (excimer laser); the manufacturer given most often on reports is Abbott Medical Optics; received from December 2013 to November 2020. 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 (94.2%) and malfunction (5.8%); 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 device displays incorrect message (6.3%), device operates differently than expected (3.1%) and mechanical problem (1.6%). The patient problems coded most often are keratitis, visual impairment and blurred vision. 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 S4-Ir-Etl was received in the five years to August 2026; the latest was received in November 2020.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury94.2%180

Malfunction5.8%11

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%191

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

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
Device displays incorrect message	12	6.3%	2.9%
Device operates differently than expectedthe device behaved unexpectedly	6	3.1%	4%
Mechanical problema mechanical problem	3	1.6%	0.2%
Suction problem	3	1.6%	0.1%
Insufficient device problem information	2	1%	13.4%
Malposition of device	2	1%	0.1%
Overcorrection	2	1%	1.1%
Unintended movement	2	1%	0.3%
Device handling problem	1	0.5%	0%
Device stops intermittentlythe device stopped now and then	1	0.5%	0.1%
Excess flow or over-infusion	1	0.5%	0%
Optical problem	1	0.5%	0%
Positioning problem	1	0.5%	0%
Smoking	1	0.5%	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	36	18.8%
Visual impairmentreduced vision	36	18.8%
Blurred vision	29	15.2%
Corneal clouding/hazing	17	8.9%
Irritationirritation	11	5.8%
Loss of vision	11	5.8%
Painpain, site not specified	10	5.2%
Visual disturbances	9	4.7%
Discomfortdiscomfort	8	4.2%
Foreign body sensation in eye	6	3.1%
Corneal abrasion	5	2.6%
Dry eye(s)	5	2.6%
Corneal infiltrates	4	2.1%
Erosion	4	2.1%
Excessive tear production	4	2.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	S4-Ir-Etl	Product code LZS	All MAUDE reports
Reports	191	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	94.2%	84.6%	36.2%
Classified as malfunction	5.8%	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%
Allegretto Wave	198	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 S4-Ir-Etl reports

How many FDA reports name S4-Ir-Etl?

191 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 (94.2%) and malfunction (5.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device displays incorrect message (6.3%), device operates differently than expected (3.1%), mechanical problem (1.6%), suction problem (1.6%) and insufficient device problem information (1%). 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 S4-Ir-Etl 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.