Devices › Light adjustable lens (lal) and light delivery device (ldd)
Device brand name · Light adjustable lens lal
Light Adjustable Lens (LAL): medical device reports filed with FDA
888 reports name it, 2021–2026. Manufacturer given most often on reports: Rxsight. Product code PZK.
- 888
- device reports naming the brand
- 0% of all MAUDE reports · about 162 a year
- 288
- reports, 12 months to August 2026
- 201 in the 12 months before
- 0.3%
- classified as malfunction
- 0.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
888 medical device reports received by FDA name the brand "Light Adjustable Lens (LAL)" (light adjustable lens lal); the manufacturer given most often on reports is Rxsight; received from January 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
288 reports arrived in the 12 months to August 2026, up 43% from 201 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 (99.7%) and malfunction (0.3%); across all light adjustable lens (lal) and light delivery device (ldd) reports (product code PZK) death is recorded in 0% and malfunction in 0.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are optical problem (12.6%), optical decentration (5.9%) and patient-device incompatibility (5.6%). The patient problems coded most often are visual impairment, blurred vision 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 1,385 reports carrying product code PZK. 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 |
|---|---|---|---|
| Optical problem | 112 | 12.6% | 9.2% |
| Optical decentration | 52 | 5.9% | 5.9% |
| Patient-device incompatibilitythe device did not suit the patient | 50 | 5.6% | 4.8% |
| Insufficient device problem information | 44 | 5% | 3.8% |
| Improper or incorrect procedure or method | 25 | 2.8% | 2% |
| Optical distortion | 19 | 2.1% | 1.7% |
| Device dislodged or dislocated | 15 | 1.7% | 1.3% |
| Malposition of device | 4 | 0.5% | 0.3% |
| Material opacification | 3 | 0.3% | 0.2% |
| Patient device interaction problem | 3 | 0.3% | 0.6% |
| Detachment of device or device componentpart of the device came off | 2 | 0.2% | 0.2% |
| Device handling problem | 2 | 0.2% | 0.1% |
| Unintended movement | 2 | 0.2% | 0.3% |
| Device damaged by another device | 1 | 0.1% | 0.1% |
| Material split, cut or torn | 1 | 0.1% | 0.1% |
| Material twisted/bent | 1 | 0.1% | 0% |
| Mechanical jam | 1 | 0.1% | 0% |
| Mechanical problema mechanical problem | 1 | 0.1% | 0% |
| Misfocusing | 1 | 0.1% | 0.1% |
| Unstable | 1 | 0.1% | 0.1% |
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 |
|---|---|---|
| Visual impairmentreduced vision | 238 | 26.8% |
| Blurred vision | 214 | 24.1% |
| Visual disturbances | 168 | 18.9% |
| Capsular bag tear | 134 | 15.1% |
| Diplopia/double vision | 19 | 2.1% |
| Eye irritationeye irritation | 4 | 0.5% |
| Halo | 4 | 0.5% |
| Photophobiasensitivity to light | 4 | 0.5% |
| Corneal edema | 3 | 0.3% |
| Autoimmune disorder | 2 | 0.2% |
| Endophthalmitisinfection inside the eye | 2 | 0.2% |
| Excessive tear production | 2 | 0.2% |
| Eye injury | 2 | 0.2% |
| Eye paineye pain | 2 | 0.2% |
| Hypersensitivity/allergic reaction | 2 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Light Adjustable Lens (LAL) | Product code PZK | All MAUDE reports |
|---|---|---|---|
| Reports | 888 | 1,385 | 26,136,888 |
| Share of that pool | — | 64.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 99.7% | 99.6% | 36.2% |
| Classified as malfunction | 0.3% | 0.3% | 62.3% |
| Filed by the manufacturer | 99.9% | 97.8% | 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 PZK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Light Adjustable Lens+ (LAL+) | 418 | 205 | 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 Light Adjustable Lens (LAL) reports
How many FDA reports name Light Adjustable Lens (LAL)?
888 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 288 in the latest 12 months.
What kinds of events are reported?
injury (99.7%) and malfunction (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
optical problem (12.6%), optical decentration (5.9%), patient-device incompatibility (5.6%), insufficient device problem information (5%) and improper or incorrect procedure or method (2.8%). 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 Light Adjustable Lens (LAL) 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.