Devices › Ophthalmic femtosecond laser
Device brand name · Ophthalmic femtosecond laser
Lensx Laser System: medical device reports filed with FDA
2,632 reports name it, 2011–2026. Manufacturer given most often on reports: Alcon Lensx. Product code OOE.
- 2,632
- device reports naming the brand
- 0% of all MAUDE reports · about 175 a year
- 119
- reports, 12 months to August 2026
- 206 in the 12 months before
- 40.8%
- classified as malfunction
- 40.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 2,632 reports that name the brand "Lensx Laser System" (ophthalmic femtosecond laser), received between June 2011 and August 2026; the manufacturer given most often on reports is Alcon Lensx. Spellings of one product vary from report to report.
119 reports arrived in the 12 months to August 2026, down 42% from 206 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 (59.2%) and malfunction (40.8%); across all ophthalmic femtosecond laser reports (product code OOE) death is recorded in 0% and malfunction in 40.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (13.6%), failure to align (12.4%) and insufficient device problem information (10.7%). The patient problems coded most often are capsular bag tear, eye injury and appropriate clinical signs, symptoms and conditions term/code not available. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,029 reports carrying product code OOE. 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 operates differently than expectedthe device behaved unexpectedly | 357 | 13.6% | 9.8% |
| Failure to align | 327 | 12.4% | 8.3% |
| Insufficient device problem information | 281 | 10.7% | 8.2% |
| Failure to cut | 241 | 9.2% | 5.3% |
| Unintended movement | 87 | 3.3% | 1.8% |
| Suction problem | 38 | 1.4% | 3.1% |
| Device displays incorrect message | 30 | 1.1% | 1% |
| Therapeutic or diagnostic output failure | 27 | 1% | 0.6% |
| Air leak | 23 | 0.9% | 0.6% |
| Decrease in suction | 21 | 0.8% | 12.1% |
| Positioning problem | 20 | 0.8% | 0.5% |
| Detachment of device component | 16 | 0.6% | 0.3% |
| Improper or incorrect procedure or method | 16 | 0.6% | 1.1% |
| Application program freezes or fails to launch | 15 | 0.6% | 0.3% |
| Breakthe device broke | 14 | 0.5% | 0.5% |
| Malposition of device | 14 | 0.5% | 0.5% |
| Difficult to open or close | 13 | 0.5% | 0.3% |
| Inadequacy of device shape and/or size | 13 | 0.5% | 0.4% |
| Suction failure | 13 | 0.5% | 0.3% |
| Material integrity problema problem with the device material | 12 | 0.5% | 0.2% |
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 |
|---|---|---|
| Capsular bag tear | 470 | 17.9% |
| Eye injury | 159 | 6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 148 | 5.6% |
| Vitrectomy | 81 | 3.1% |
| Tissue damage | 54 | 2.1% |
| No patient involvement | 44 | 1.7% |
| Rupturethe device burst | 37 | 1.4% |
| Complaint, ill-defined | 34 | 1.3% |
| Corneal edema | 34 | 1.3% |
| Injurya physical injury | 34 | 1.3% |
| Corneal perforation | 26 | 1% |
| Adhesion(s) | 25 | 0.9% |
| Visual impairmentreduced vision | 24 | 0.9% |
| Excessive tear production | 19 | 0.7% |
| Laceration(s) | 17 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lensx Laser System | Product code OOE | All MAUDE reports |
|---|---|---|---|
| Reports | 2,632 | 5,029 | 26,136,888 |
| Share of that pool | — | 52.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 59.2% | 57.7% | 36.2% |
| Classified as malfunction | 40.8% | 40.7% | 62.3% |
| Filed by the manufacturer | 100% | 98.2% | 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 OOE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Catalys System | 958 | 67 | 0% |
| WaveLight FS200 Femtosecond Laser | 4,653 | 486 | 0% |
| WaveLight FS200 EasyPack Patient Interface | 411 | 24 | 0% |
| Lasik | 493 | 7 | 1.2% |
| Alcon | 180 | 2 | 0% |
| Infiniti Vision System Ozil | 3,530 | 0 | 0% |
| S4-Ir-Etl | 191 | 0 | 0% |
| WaveLight EX500 Excimer Laser | 2,123 | 116 | 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 Lensx Laser System reports
How many FDA reports name Lensx Laser System?
2,632 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 119 in the latest 12 months.
What kinds of events are reported?
injury (59.2%) and malfunction (40.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (13.6%), failure to align (12.4%), insufficient device problem information (10.7%), failure to cut (9.2%) and unintended movement (3.3%). 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 Lensx Laser System 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.