Devices › Lens, intraocular, phakic
Device brand name · Phakic intraocular lens
Implantable Collamer Lens: medical device reports filed with FDA
990 reports name it, 2007–2025. Manufacturer given most often on reports: Staar Surgical. Product code MTA.
- 990
- device reports naming the brand
- 0% of all MAUDE reports · about 51 a year
- 1
- reports, 12 months to August 2026
- 3 in the 12 months before
- 42.4%
- classified as malfunction
- 19.2% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 990 reports that name the brand "Implantable Collamer Lens" (phakic intraocular lens), received between January 2007 and September 2025; the manufacturer given most often on reports is Staar Surgical. Spellings of one product vary from report to report.
1 reports arrived in the 12 months to August 2026, down 67% from 3 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 (57.5%), malfunction (42.4%) and death (0.1%); across all lens, intraocular, phakic reports (product code MTA) death is recorded in 0% and malfunction in 19.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are inadequacy of device shape and/or size (22.4%), misfocusing (18%) and device operates differently than expected (14.2%). The patient problems coded most often are blurred vision, intraocular pressure increased 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 22,089 reports carrying product code MTA. 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 |
|---|---|---|---|
| Inadequacy of device shape and/or size | 222 | 22.4% | 48.2% |
| Misfocusing | 178 | 18% | 4.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 141 | 14.2% | 5.4% |
| Device dislodged or dislocated | 131 | 13.2% | 2.1% |
| Off-label use | 120 | 12.1% | 11.6% |
| Improper or incorrect procedure or method | 29 | 2.9% | 0.3% |
| Patient-device incompatibilitythe device did not suit the patient | 18 | 1.8% | 0.8% |
| Optical problem | 16 | 1.6% | 1.6% |
| Unintended movement | 14 | 1.4% | 2% |
| Insufficient device problem information | 8 | 0.8% | 1.8% |
| Contamination /decontamination problem | 7 | 0.7% | 0% |
| Ejection problem | 4 | 0.4% | 0% |
| Activation failure | 3 | 0.3% | 0.1% |
| Contamination | 3 | 0.3% | 0% |
| Device contamination with chemical or other material | 3 | 0.3% | 0.1% |
| Positioning failure | 3 | 0.3% | 0.2% |
| Compatibility problem | 1 | 0.1% | 0% |
| Failure to unfold or unwrap | 1 | 0.1% | 0% |
| Inaccurate information | 1 | 0.1% | 0% |
| Material discolored | 1 | 0.1% | 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 |
|---|---|---|
| Blurred vision | 233 | 23.5% |
| Intraocular pressure increasedraised pressure in the eye | 45 | 4.5% |
| Visual disturbances | 44 | 4.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 32 | 3.2% |
| No patient involvement | 22 | 2.2% |
| Halo | 21 | 2.1% |
| Cataractclouding of the eye lens | 11 | 1.1% |
| Corneal edema | 11 | 1.1% |
| Painpain, site not specified | 10 | 1% |
| Pupillary block | 10 | 1% |
| Headachehead pain | 9 | 0.9% |
| Iritis | 8 | 0.8% |
| Glaucomaraised pressure in the eye | 5 | 0.5% |
| Corneal decompensation | 4 | 0.4% |
| Inflammationinflammation | 4 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Implantable Collamer Lens | Product code MTA | All MAUDE reports |
|---|---|---|---|
| Reports | 990 | 22,089 | 26,136,888 |
| Share of that pool | — | 4.5% | 0% |
| Classified as death, per 1,000 reports | 1 | 0 | 9 |
| Classified as injury | 57.5% | 80.4% | 36.2% |
| Classified as malfunction | 42.4% | 19.2% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.9% | 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 MTA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Implantable Collamer Lens Icl | 29,062 | 41 | 0% |
| Icl Implantable Collamer Lens | 4,842 | 0 | 0% |
| Visian ICL (Implantable Collamer Lens) | 2,831 | 10 | 0% |
| EVO/EVO+VISIAN Implantable Collamer Lens | 1,489 | 978 | 0% |
| EVO/EVO+ VISIAN Implantable Collamer Lens | 846 | 672 | 0% |
| EVO/EVO+ VISIAN Implantable Collamer Lens (ICL) | 497 | 405 | 0% |
| EVO/EVO + VISIAN Implantable Collamer Lens (ICL) | 319 | 317 | 0% |
| Silicone Ultraviolet-Absorbing Posterior Chamber Three Piece Foldable Intraocula | 1,138 | 0 | 0% |
| Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocul | 628 | 0 | 0% |
| Collamer Ultraviolet-Absorbing Posterior Chamber Three Piece Foldable Intraocula | 603 | 0 | 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 Implantable Collamer Lens reports
How many FDA reports name Implantable Collamer Lens?
990 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.
What kinds of events are reported?
injury (57.5%), malfunction (42.4%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
inadequacy of device shape and/or size (22.4%), misfocusing (18%), device operates differently than expected (14.2%), device dislodged or dislocated (13.2%) and off-label use (12.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Implantable Collamer Lens 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.