Lens, intraocular, toric optics: medical device reports filed with FDA

8,214 reports carry this product code, 2008–2026; 18 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

8,214
reports with this product code: 0% of all MAUDE reports; 1,757
reports, 12 months to August 2026: 1,673 in the 12 months before; 42%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code MJP is FDA's classification for "Lens, intraocular, toric optics" (ophthalmic panel), a class 3 device. 8,214 medical device reports carry this product code, 0% of the MAUDE database, from February 2008 to August 2026.

1,757 reports arrived in the 12 months to August 2026, close to the 1,673 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 (54.5%), malfunction (42%) and other (3.5%). 18 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
AcrySof IQ Toric Singlepiece IOL	1,743	60	0%	30.8%
Tecnis Iol	1,159	715	0%	42.9%
Clareon Toric Aspheric Hydrophobic Acrylic IOL with AutonoME Delivery System	566	235	0%	94.4%
Clareon Toric IOL	566	207	0%	69.5%
Clareon PanOptix Toric Trifocal UV Absorbing IOL	488	75	0%	18%
Clareon PanOptix Toric Trifocal Hydrophobic IOL	430	136	0%	45.3%
Clareon Vivity Toric Extended Vision UV Absorbing IOL	388	95	0%	23.5%
Clareon Vivity Toric Extended Vision Hydrophobic IOL	314	119	0%	48.4%
Clareon Toric UV Absorbing IOL	309	126	0%	54%
Acrysof Restor Toric Singlepiece Iol	269	0	0%	26%
Acrysof Iq Toric	258	0	0%	9.1%
Acrysof Toric	251	0	0%	18.2%
Trulign Toric Posterior Chamber Iol	179	0	0%	0.6%
CLAREON PANOPTIX PRO Trifocal TORIC UV Absorbing IOL w/AutonoME Delivery System	150	146	0%	42.7%
Tecnis	26	0	0.1%	18.1%
Tecnis Symfony Toric	4	0	0%	7.3%
Clareon Vivity Extended Vision Hydrophobic IOL	1	92	0%	51.2%
Crystalens Intraocular Lens	1	0	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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Alcon Research - Huntington	3,074	37.4%
Alcon Laboratories Ireland	2,782	33.9%
Amo Puerto Rico Mfg	1,300	15.8%
Bausch + Lomb	327	4%
Alcon Research / Huntington	324	3.9%
Alcon Research /Huntington	147	1.8%
Amo Manufacturing Netherlands	84	1%
Bausch & Lomb	53	0.6%
Johnson & Johnson Surgical Vision	16	0.2%
Abbott Medical Optics	14	0.2%
Alcon Laboratories	5	0.1%
Staar Surgical	5	0.1%
Abbott	2	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%0

Injury54.5%4,474

Malfunction42%3,450

Other3.5%289

Not given0%1

Who filed

Manufacturer report99.8%8,194

Voluntary report0.2%15

User facility report0%0

Distributor report0%2

Not given0%3

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	725	8.8%
Scratched material	644	7.8%
Device dislodged or dislocated	485	5.9%
Insufficient device problem information	374	4.6%
Material discolored	275	3.3%
Device remains implanted	260	3.2%
Device difficult to setup or prepare	234	2.8%
Defective devicethe device was defective	216	2.6%
Failure to deliverthe device did not deliver the dose or item	202	2.5%
Device operates differently than expectedthe device behaved unexpectedly	196	2.4%
Material split, cut or torn	180	2.2%
Crackthe device cracked	170	2.1%
Malposition of device	168	2%
Material twisted/bent	165	2%
Unstable	130	1.6%
Failure to advance	121	1.5%
Product quality problem	104	1.3%
Device damaged by another device	86	1%
Material opacification	77	0.9%
Inaccurate delivery	76	0.9%

Questions about lens, intraocular, toric optics reports

What is product code MJP?

FDA's classification code for "Lens, intraocular, toric optics", class 3, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

8,214 reports through August 2026, 1,757 of them in the latest 12 months.

Which brands appear most often?

AcrySof IQ Toric Singlepiece IOL (1,743), Tecnis Iol (1,159), Clareon Toric Aspheric Hydrophobic Acrylic IOL with AutonoME Delivery System (566), Clareon Toric IOL (566) and Clareon PanOptix Toric Trifocal UV Absorbing IOL (488). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.