Device brand name · Intraocular lens
UNK_Monofocal IOL: medical device reports filed with FDA
172 reports name it, 2021–2026. Manufacturer given most often on reports: Amo Puerto Rico Mfg. Product code HQL.
- 172
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 43
- reports, 12 months to August 2026
- 38 in the 12 months before
- 53.5%
- classified as malfunction
- 52.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 172 reports that name the brand "UNK_Monofocal IOL" (intraocular lens), received between February 2021 and August 2026; the manufacturer given most often on reports is Amo Puerto Rico Mfg. Spellings of one product vary from report to report.
43 reports arrived in the 12 months to August 2026, up 13% from 38 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 (53.5%) and injury (46.5%); 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 break (34.3%), scratched material (6.4%) and contamination (4.1%). The patient problems coded most often are blurred vision, eye injury and visual disturbances. 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 |
|---|---|---|---|
| Breakthe device broke | 59 | 34.3% | 9.8% |
| Scratched material | 11 | 6.4% | 3.9% |
| Contamination | 7 | 4.1% | 0.9% |
| Material fragmentation | 6 | 3.5% | 0.8% |
| Material opacification | 5 | 2.9% | 1.6% |
| Physical resistance/sticking | 5 | 2.9% | 0.4% |
| Application program problem: dose calculation error | 3 | 1.7% | 0% |
| Ejection problem | 3 | 1.7% | 0.6% |
| Failure to fold | 3 | 1.7% | 0.5% |
| Crackthe device cracked | 2 | 1.2% | 2.8% |
| Device difficult to setup or prepare | 2 | 1.2% | 1.3% |
| Device dislodged or dislocated | 2 | 1.2% | 1.1% |
| Difficult to fold, unfold or collapse | 2 | 1.2% | 0.7% |
| Operating system becomes nonfunctional | 2 | 1.2% | 0.1% |
| Unstable | 2 | 1.2% | 0.1% |
| Delivered as unsterile product | 1 | 0.6% | 0.1% |
| Difficult to insertthe device was hard to insert | 1 | 0.6% | 1.5% |
| Incorrect, inadequate or imprecise result or readings | 1 | 0.6% | 0% |
| Manufacturing, packaging or shipping problem | 1 | 0.6% | 0.1% |
| Material split, cut or torn | 1 | 0.6% | 2.1% |
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 |
|---|---|---|
| Blurred vision | 24 | 14% |
| Eye injury | 22 | 12.8% |
| Visual disturbances | 19 | 11% |
| Posterior capsule opacification | 13 | 7.6% |
| Halo | 11 | 6.4% |
| Visual impairmentreduced vision | 7 | 4.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 2.9% |
| Capsular bag tear | 4 | 2.3% |
| Headachehead pain | 4 | 2.3% |
| Inflammationinflammation | 4 | 2.3% |
| Adhesion(s) | 3 | 1.7% |
| Corneal edema | 3 | 1.7% |
| Discomfortdiscomfort | 3 | 1.7% |
| Glaucomaraised pressure in the eye | 3 | 1.7% |
| Intraocular pressure increasedraised pressure in the eye | 3 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | UNK_Monofocal IOL | Product code HQL | All MAUDE reports |
|---|---|---|---|
| Reports | 172 | 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 | 46.5% | 42.8% | 36.2% |
| Classified as malfunction | 53.5% | 52.8% | 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 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 UNK_Monofocal IOL reports
How many FDA reports name UNK_Monofocal IOL?
172 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 43 in the latest 12 months.
What kinds of events are reported?
malfunction (53.5%) and injury (46.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (34.3%), scratched material (6.4%), contamination (4.1%), material fragmentation (3.5%) and material opacification (2.9%). 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 UNK_Monofocal IOL 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.