Devices › Ophthalmic femtosecond laser
Device brand name · Catalys
Catalys System: medical device reports filed with FDA
958 reports name it, 2015–2026. Manufacturer given most often on reports: Amo Manufacturing USA. Product code OOE.
- 958
- device reports naming the brand
- 0% of all MAUDE reports · about 83 a year
- 67
- reports, 12 months to August 2026
- 63 in the 12 months before
- 53%
- classified as malfunction
- 40.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
958 medical device reports received by FDA name the brand "Catalys System" (catalys); the manufacturer given most often on reports is Amo Manufacturing USA; received from January 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
67 reports arrived in the 12 months to August 2026, close to the 63 of 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 malfunction (53%) and injury (47%); 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 decrease in suction (47.1%), suction problem (5.4%) and computer software problem (2.3%). The patient problems coded most often are capsular bag tear, vitrectomy 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 |
|---|---|---|---|
| Decrease in suction | 451 | 47.1% | 12.1% |
| Suction problem | 52 | 5.4% | 3.1% |
| Computer software problema software problem | 22 | 2.3% | 1% |
| Device operates differently than expectedthe device behaved unexpectedly | 21 | 2.2% | 9.8% |
| Failure to sense | 10 | 1% | 0.2% |
| Unexpected shutdown | 8 | 0.8% | 0.1% |
| Computer system security problem | 6 | 0.6% | 0.1% |
| Device displays incorrect message | 6 | 0.6% | 1% |
| Mechanical problema mechanical problem | 6 | 0.6% | 0.3% |
| Gradient increase | 4 | 0.4% | 0.1% |
| Increase in pressure | 4 | 0.4% | 0.1% |
| Insufficient device problem information | 4 | 0.4% | 8.2% |
| Display or visual feedback problem | 3 | 0.3% | 0.1% |
| Suction failure | 3 | 0.3% | 0.3% |
| Application program freezes or fails to launch | 2 | 0.2% | 0.3% |
| Device damaged prior to usethe device was damaged before use | 2 | 0.2% | 0% |
| Device difficult to setup or prepare | 2 | 0.2% | 0.1% |
| Failure to cut | 2 | 0.2% | 5.3% |
| Failure to power up | 2 | 0.2% | 0% |
| Programming issue | 2 | 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 |
|---|---|---|
| Capsular bag tear | 278 | 29% |
| Vitrectomy | 71 | 7.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 62 | 6.5% |
| Corneal perforation | 35 | 3.7% |
| Eye injury | 17 | 1.8% |
| Macular edema | 15 | 1.6% |
| Visual impairmentreduced vision | 14 | 1.5% |
| Wound dehiscencea wound reopened | 14 | 1.5% |
| Zonular dehiscence | 10 | 1% |
| Corneal edema | 9 | 0.9% |
| Vitreous loss | 8 | 0.8% |
| Corneal abrasion | 6 | 0.6% |
| Blurred vision | 4 | 0.4% |
| Hyphema | 4 | 0.4% |
| Intraocular pressure increasedraised pressure in the eye | 4 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Catalys System | Product code OOE | All MAUDE reports |
|---|---|---|---|
| Reports | 958 | 5,029 | 26,136,888 |
| Share of that pool | — | 19% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 47% | 57.7% | 36.2% |
| Classified as malfunction | 53% | 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 |
|---|---|---|---|
| Lensx Laser System | 2,632 | 119 | 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 Catalys System reports
How many FDA reports name Catalys System?
958 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 67 in the latest 12 months.
What kinds of events are reported?
malfunction (53%) and injury (47%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
decrease in suction (47.1%), suction problem (5.4%), computer software problem (2.3%), device operates differently than expected (2.2%) and failure to sense (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 Catalys 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.