Device brand name · Laser ophthalmic
PurePoint Laser: medical device reports filed with FDA
666 reports name it, 2015–2026. Manufacturer given most often on reports: Alcon Research - Irvine Technology Center. Product code HQF.
- 666
- device reports naming the brand
- 0% of all MAUDE reports · about 59 a year
- 57
- reports, 12 months to August 2026
- 72 in the 12 months before
- 96.1%
- classified as malfunction
- 68.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 666 reports that name the brand "PurePoint Laser" (laser ophthalmic), received between March 2015 and August 2026; the manufacturer given most often on reports is Alcon Research - Irvine Technology Center. Spellings of one product vary from report to report.
57 reports arrived in the 12 months to August 2026, down 21% from 72 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 malfunction (96.1%) and injury (3.9%); across all laser, ophthalmic reports (product code HQF) death is recorded in 0% and malfunction in 68.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are energy output problem (29.6%), failure to fire (13.8%) and power problem (10.2%). The patient problems coded most often are no patient involvement, eye pain and inflammation. 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 1,529 reports carrying product code HQF. 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 |
|---|---|---|---|
| Energy output problem | 197 | 29.6% | 14.8% |
| Failure to fire | 92 | 13.8% | 6.9% |
| Power problem | 68 | 10.2% | 4.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 47 | 7.1% | 7.7% |
| Output below specifications | 41 | 6.2% | 3.1% |
| Failure to deliver energy | 27 | 4.1% | 3% |
| Loss of powerthe device lost power | 24 | 3.6% | 2.7% |
| Unexpected shutdown | 18 | 2.7% | 1% |
| Output problem | 14 | 2.1% | 1.6% |
| Electrical /electronic property probleman electrical or electronic problem | 13 | 2% | 0.8% |
| Device displays incorrect message | 10 | 1.5% | 3.9% |
| Intermittent energy output | 10 | 1.5% | 0.7% |
| Self-activation or keying | 10 | 1.5% | 0.7% |
| Device inoperablethe device could not be used | 8 | 1.2% | 1.5% |
| Therapeutic or diagnostic output failure | 8 | 1.2% | 0.5% |
| Display or visual feedback problem | 7 | 1.1% | 0.5% |
| Firing problem | 7 | 1.1% | 0.7% |
| Defective component | 6 | 0.9% | 0.8% |
| No display/image | 6 | 0.9% | 0.3% |
| Inappropriate or unexpected reset | 5 | 0.8% | 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 |
|---|---|---|
| No patient involvement | 39 | 5.9% |
| Eye paineye pain | 5 | 0.8% |
| Inflammationinflammation | 5 | 0.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 0.6% |
| Blurred vision | 3 | 0.5% |
| Electric shockan electric shock | 3 | 0.5% |
| Loss of vision | 3 | 0.5% |
| Burn(s)a burn | 2 | 0.3% |
| Intraocular pressure increasedraised pressure in the eye | 2 | 0.3% |
| Retinal degeneration | 2 | 0.3% |
| Corneal abrasion | 1 | 0.2% |
| Corneal edema | 1 | 0.2% |
| Eye infections | 1 | 0.2% |
| Eye injury | 1 | 0.2% |
| Headachehead pain | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PurePoint Laser | Product code HQF | All MAUDE reports |
|---|---|---|---|
| Reports | 666 | 1,529 | 26,136,888 |
| Share of that pool | — | 43.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 3.9% | 28.1% | 36.2% |
| Classified as malfunction | 96.1% | 68.8% | 62.3% |
| Filed by the manufacturer | 100% | 89.3% | 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 HQF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Intralase Fs Laser | 340 | 0 | 0% |
| Ophthalas 532 Eyelite Laser System | 182 | 0 | 0% |
| Lasik | 493 | 7 | 1.2% |
| Alcon | 180 | 2 | 0% |
| Millennium Microsurgical System | 152 | 0 | 0% |
| Stellaris Pc Vision Enhancement System | 366 | 1 | 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 PurePoint Laser reports
How many FDA reports name PurePoint Laser?
666 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 57 in the latest 12 months.
What kinds of events are reported?
malfunction (96.1%) and injury (3.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
energy output problem (29.6%), failure to fire (13.8%), power problem (10.2%), device operates differently than expected (7.1%) and output below specifications (6.2%). 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 PurePoint Laser 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.