Extended depth of focus intraocular lens: medical device reports filed with FDA

5,952 reports carry this product code, 2016–2026; 15 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.

5,952
reports with this product code: 0% of all MAUDE reports; 477
reports, 12 months to August 2026: 550 in the 12 months before; 20.2%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code POE is FDA's classification for "Extended depth of focus intraocular lens" (ophthalmic panel), a class 3 device. 5,952 medical device reports carry this product code, 0% of the MAUDE database, from August 2016 to August 2026.

477 reports arrived in the 12 months to August 2026, down 13% from 550 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 (79.8%) and malfunction (20.2%). 15 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
Tecnis Symfony	1,578	0	0%	5.8%
Tecnis Symfony Toric	1,035	0	0%	7.3%
AcrySof IQ Vivity Extended Vision IOL	676	50	0%	44.2%
Clareon Vivity Extended Vision UV Absorbing IOL	448	113	0%	24.5%
Acrysof Iq Vivity Toric Extended Vision Iol	350	31	0%	43.6%
Tecnis Iol	301	715	0%	42.9%
Acrysof Iq Vivity Extended Vision Uv Absorbing Iol	296	0	0%	18.2%
Clareon Vivity Extended Vision Hydrophobic IOL	296	92	0%	51.2%
Acrysof Iq Vivity Toric Extended Vision Uv Absorbing Iol	206	2	0%	14.1%
Tecnis Simplicity	103	1,217	0%	74.7%
Tecnis 1 Multifocal	10	0	0%	6.4%
Tecnis	6	0	0.1%	18.1%
Tecnis 1-Piece	1	0	0%	36.1%
Tecnis Itec Preloaded 1-Piece Iol	1	0	0%	69.2%
UNK_Monofocal IOL	1	43	0%	53.5%

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	1,904	32%
Johnson & Johnson Surgical Vision	1,614	27.1%
Abbott Medical Optics	1,002	16.8%
Alcon Laboratories Ireland	477	8%
Amo Manufacturing Netherlands	392	6.6%
Amo Puerto Rico Mfg	382	6.4%
Bausch + Lomb	55	0.9%

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

Injury79.8%4,749

Malfunction20.2%1,203

Other0%0

Not given0%0

Who filed

Manufacturer report99.9%5,944

Voluntary report0.1%7

User facility report0%0

Distributor report0%0

Not given0%1

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

Device problems coded

Device problem (FDA code)	Reports	Share
Scratched material	362	6.1%
Breakthe device broke	225	3.8%
Inadequacy of device shape and/or size	179	3%
Device dislodged or dislocated	163	2.7%
Unintended movement	161	2.7%
Defective devicethe device was defective	102	1.7%
Crackthe device cracked	75	1.3%
Device contamination with chemical or other material	67	1.1%
Material split, cut or torn	67	1.1%
Material opacification	45	0.8%
Product quality problem	40	0.7%
Failure to deliverthe device did not deliver the dose or item	39	0.7%
Unstable	38	0.6%
Material twisted/bent	37	0.6%
Malposition of device	36	0.6%
Device difficult to setup or prepare	35	0.6%
Insufficient device problem information	28	0.5%
Device damaged by another device	26	0.4%
Defective component	24	0.4%
Failure to advance	24	0.4%

Questions about extended depth of focus intraocular lens reports

What is product code POE?

FDA's classification code for "Extended depth of focus intraocular lens", class 3, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,952 reports through August 2026, 477 of them in the latest 12 months.

Which brands appear most often?

Tecnis Symfony (1,578), Tecnis Symfony Toric (1,035), AcrySof IQ Vivity Extended Vision IOL (676), Clareon Vivity Extended Vision UV Absorbing IOL (448) and Acrysof Iq Vivity Toric Extended Vision Iol (350). 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.