Devices › Aid, surgical, viscoelastic
Device brand name · Aid surgical viscoelastic
VISCOAT Ophthalmic ViscoSurgical Device: medical device reports filed with FDA
229 reports name it, 2015–2026. Manufacturer given most often on reports: Alcon - Couvreur /Alcon - Belgium. Product code LZP.
- 229
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 40
- reports, 12 months to August 2026
- 27 in the 12 months before
- 14.4%
- classified as malfunction
- 30.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
229 medical device reports received by FDA name the brand "VISCOAT Ophthalmic ViscoSurgical Device" (aid surgical viscoelastic); the manufacturer given most often on reports is Alcon - Couvreur /Alcon - Belgium; received from March 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
40 reports arrived in the 12 months to August 2026, up 48% from 27 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 (85.6%) and malfunction (14.4%); across all aid, surgical, viscoelastic reports (product code LZP) death is recorded in 0% and malfunction in 30.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device contamination with chemical or other material (5.7%), insufficient device problem information (4.8%) and detachment of device or device component (2.2%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, toxic anterior segment syndrome (tass) and corneal edema. 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 2,952 reports carrying product code LZP. 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 contamination with chemical or other material | 13 | 5.7% | 7.6% |
| Insufficient device problem information | 11 | 4.8% | 5.3% |
| Detachment of device or device componentpart of the device came off | 5 | 2.2% | 1.1% |
| Device handling problem | 5 | 2.2% | 0.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 1.7% | 0.6% |
| Particulates | 4 | 1.7% | 0.9% |
| Complete blockage | 2 | 0.9% | 0.3% |
| Defective component | 2 | 0.9% | 0.5% |
| Difficult to removethe device was hard to remove | 2 | 0.9% | 0.6% |
| Fitting problem | 2 | 0.9% | 0.1% |
| Physical resistance/sticking | 2 | 0.9% | 0.1% |
| Air leak | 1 | 0.4% | 0% |
| Air/gas in device | 1 | 0.4% | 0% |
| Breakthe device broke | 1 | 0.4% | 0.7% |
| Burst container or vessel | 1 | 0.4% | 0.1% |
| Chemical problem | 1 | 0.4% | 0% |
| Contamination | 1 | 0.4% | 10.4% |
| Contamination /decontamination problem | 1 | 0.4% | 0.4% |
| Contamination of device ingredient or reagent | 1 | 0.4% | 0.1% |
| Detachment of device component | 1 | 0.4% | 4.4% |
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 |
|---|---|---|
| Appropriate clinical signs, symptoms and conditions term/code not available | 32 | 14% |
| Toxic anterior segment syndrome (tass) | 32 | 14% |
| Corneal edema | 28 | 12.2% |
| Intraocular pressure increasedraised pressure in the eye | 26 | 11.4% |
| Endophthalmitisinfection inside the eye | 25 | 10.9% |
| Blurred vision | 23 | 10% |
| Uveitis | 18 | 7.9% |
| Hypopyon | 14 | 6.1% |
| Inflammationinflammation | 13 | 5.7% |
| Eye burn | 12 | 5.2% |
| Clouding, central corneal | 8 | 3.5% |
| Eye paineye pain | 7 | 3.1% |
| Iritis | 6 | 2.6% |
| Capsular bag tear | 5 | 2.2% |
| Corneal clouding/hazing | 5 | 2.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | VISCOAT Ophthalmic ViscoSurgical Device | Product code LZP | All MAUDE reports |
|---|---|---|---|
| Reports | 229 | 2,952 | 26,136,888 |
| Share of that pool | — | 7.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 85.6% | 68% | 36.2% |
| Classified as malfunction | 14.4% | 30.2% | 62.3% |
| Filed by the manufacturer | 100% | 96.4% | 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 LZP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Healon | 242 | 0 | 0.4% |
| Viscoat | 220 | 0 | 0.5% |
| PROVISC Ophthalmic ViscoSurgical Device | 175 | 30 | 0% |
| Duovisc | 160 | 0 | 0% |
| Animas Insulin Infusion Pump | 26,293 | 0 | 0.3% |
| Essure | 74,072 | 435 | 0.2% |
| Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Large | 308 | 0 | 0% |
| Veritas Collagen Matrix | 206 | 0 | 0.5% |
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 VISCOAT Ophthalmic ViscoSurgical Device reports
How many FDA reports name VISCOAT Ophthalmic ViscoSurgical Device?
229 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 40 in the latest 12 months.
What kinds of events are reported?
injury (85.6%) and malfunction (14.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device contamination with chemical or other material (5.7%), insufficient device problem information (4.8%), detachment of device or device component (2.2%), device handling problem (2.2%) and device operates differently than expected (1.7%). 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 VISCOAT Ophthalmic ViscoSurgical Device 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.