Device brand name · Intraocular lens
Alcon: medical device reports filed with FDA
180 reports name it, 1996–2025. Manufacturer given most often on reports: Alcon Laboratories. Product code HQL.
- 180
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 2
- reports, 12 months to August 2026
- 2 in the 12 months before
- 36.7%
- classified as malfunction
- 52.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
180 medical device reports received by FDA name the brand "Alcon" (intraocular lens); the manufacturer given most often on reports is Alcon Laboratories; received from July 1996 to November 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
2 reports arrived in the 12 months to August 2026, close to the 2 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 injury (40.6%), malfunction (36.7%) and other (18.3%); across all intraocular lens reports (product code HQL) death is recorded in 0% and malfunction in 52.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fracture (5%), replace (5%) and detachment of device component (3.3%). The patient problems coded most often are eye burn, burn(s) and foreign body, removal of. 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 79,755 reports carrying product code HQL. 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 |
|---|---|---|---|
| Fracturea broken bone | 9 | 5% | 0.2% |
| Replace | 9 | 5% | 1.7% |
| Detachment of device component | 6 | 3.3% | 0.5% |
| Foreign material | 6 | 3.3% | 0.3% |
| Other (for use when an appropriate device code cannot be identified) | 6 | 3.3% | 2.2% |
| Transducer probe overheating | 5 | 2.8% | 0% |
| Breakthe device broke | 4 | 2.2% | 9.8% |
| Device issuea problem with the device | 4 | 2.2% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 2.2% | 1% |
| Device remains implanted | 4 | 2.2% | 4.3% |
| Difficult to insertthe device was hard to insert | 4 | 2.2% | 1.5% |
| Particulates | 4 | 2.2% | 0.1% |
| Reactiona reaction, type not specified | 4 | 2.2% | 0.2% |
| Device displays incorrect message | 3 | 1.7% | 0% |
| Overheating of device | 3 | 1.7% | 0% |
| Thermal decomposition of device | 3 | 1.7% | 0% |
| Tip breakage | 3 | 1.7% | 0% |
| Burn hole(s) | 2 | 1.1% | 0% |
| Component(s), overheating of | 2 | 1.1% | 0% |
| Defective component | 2 | 1.1% | 2.6% |
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 |
|---|---|---|
| Eye burn | 19 | 10.6% |
| Burn(s)a burn | 14 | 7.8% |
| Foreign body, removal of | 10 | 5.6% |
| Endophthalmitisinfection inside the eye | 9 | 5% |
| Other (for use when an appropriate patient code cannot be identified) | 6 | 3.3% |
| Eye injury | 5 | 2.8% |
| Therapy/non-surgical treatment, additional | 5 | 2.8% |
| Cataractclouding of the eye lens | 4 | 2.2% |
| Surgery, prolonged | 3 | 1.7% |
| Surgical procedure | 3 | 1.7% |
| Surgical procedure aborted/stopped | 3 | 1.7% |
| Surgical procedure, additional | 3 | 1.7% |
| Visual impairmentreduced vision | 3 | 1.7% |
| Dural tear | 2 | 1.1% |
| Inflammationinflammation | 2 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Alcon | Product code HQL | All MAUDE reports |
|---|---|---|---|
| Reports | 180 | 79,755 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 40.6% | 42.8% | 36.2% |
| Classified as malfunction | 36.7% | 52.8% | 62.3% |
| Filed by the manufacturer | 0% | 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 HQL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Acrysof | 9,161 | 0 | 0% |
| Tecnis Simplicity | 5,310 | 1,217 | 0% |
| Tecnis Iol | 5,901 | 715 | 0% |
| Tecnis | 3,082 | 0 | 0.1% |
| Tecnis Itec Preloaded 1-Piece Iol | 2,435 | 0 | 0% |
| AcrySof IQ Natural Singlepiece IOL | 2,424 | 118 | 0% |
| Clareon IOL with the AutonoME Delivery System | 2,276 | 864 | 0% |
| Tecnis 1-Piece | 2,259 | 0 | 0% |
| enVista Intraocular Lens | 2,163 | 36 | 0% |
| Hydroview Intraocular Lens | 2,067 | 0 | 0% |
| Acrysof Restor | 3,801 | 0 | 0% |
| Acrysof Iq Toric | 1,905 | 0 | 0% |
| AcrySof Multipiece IOL | 1,619 | 298 | 0% |
| Silicone Advanced Optic-Violet Shield | 1,413 | 0 | 0% |
| AcrySof Singlepiece IOL | 1,211 | 131 | 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 Alcon reports
How many FDA reports name Alcon?
180 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2 in the latest 12 months.
What kinds of events are reported?
injury (40.6%), malfunction (36.7%) and other (18.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (5%), replace (5%), detachment of device component (3.3%), foreign material (3.3%) and other (for use when an appropriate device code cannot be identified) (3.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (63.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Alcon 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.