Device manufacturer, as written on reports

Alcon Research - Irvine Technology Center: medical device reports filed with FDA

22,924 reports name it as the manufacturer of the device involved, 2015–2026.

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.

22,924
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,884
reports, 12 months to August 2026: 1,788 in the 12 months before; 83.3%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

22,924 medical device reports received by FDA give Alcon Research - Irvine Technology Center as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 2015 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,884 reports arrived in the 12 months to August 2026, close to the 1,788 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 malfunction (83.3%) and injury (16.7%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
CONSTELLATION Vision System	Unit, phacofragmentation	8,419	565	0%
CENTURION Vision System	Unit, phacofragmentation	3,603	143	0%
Infiniti Vision System	Unit, phacofragmentation	3,334	0	0%
CENTURION Vision System (Active Sentry)	Unit, phacofragmentation	734	145	0%
Centurion Vision System Accessory Ozil Torsional Handpiece	Unit, phacofragmentation	651	14	0%
PurePoint Laser	Laser, ophthalmic	648	57	0%
CENTURION Vision System, Accessory, Active Sentry Handpiece	Unit, phacofragmentation	643	79	0%
Laser Probes	Instrument, vitreous aspiration and cutting, ac-powered	483	27	0%
Laureate World Phaco System	Unit, phacofragmentation	470	8	0%
Lensx Laser System	Ophthalmic femtosecond laser	449	119	0%
ORA System with VerifEye Messaging	Aberrometer, ophthalmic	438	26	0%
UNITY VCS Console	Unit, phacofragmentation	384	298	0%
INFINITI Vision System, Accessory, OZIL Torsional Handpiece	Unit, phacofragmentation	355	10	0%
Accurus Surgical System	Unit, phacofragmentation	318	0	0%
LuxOR Ophthalmic Microscopes	Microscope, operating & accessories, ac-powered, ophthalmic	268	45	0%
EDGEPLUS Valved Entry System	Cannula, trocar, ophthalmic	222	53	0%
CENTURION Vision System, Accessory, Handpiece	Unit, phacofragmentation	178	50	0%
Ophthalas 532 Eyelite Laser System	Powered laser surgical instrument	45	0	0%
Accurus High Brightness Illuminator System	—	7	1	0%
Alcon Microsurgical Instruments, Cannula Ophthalmic	Cannula, ophthalmic	2	82	0%
Infiniti Vision System Ozil	Unit, phacofragmentation	1	0	0%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
HQC	Unit, phacofragmentation	19,888	86.8%
HQF	Laser, ophthalmic	682	3%
NCF	Aberrometer, ophthalmic	645	2.8%
HQE	Instrument, vitreous aspiration and cutting, ac-powered	483	2.1%
OOE	Ophthalmic femtosecond laser	449	2%
NGY	Cannula, trocar, ophthalmic	295	1.3%
HRM	Microscope, operating & accessories, ac-powered, ophthalmic	269	1.2%
IYO	System, imaging, pulsed echo, ultrasonic	85	0.4%
GEX	Powered laser surgical instrument	61	0.3%
LRO	General surgery tray	18	0.1%

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

Death0%2

Injury16.7%3,831

Malfunction83.3%19,091

Other0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Alcon Research - Irvine Technology Center reports

How many FDA device reports name Alcon Research - Irvine Technology Center as manufacturer?

22,924 reports through August 2026, 1,884 of them in the latest 12 months.

Which of its brands appear most often?

CONSTELLATION Vision System (8,419), CENTURION Vision System (3,603), Infiniti Vision System (3,334), CENTURION Vision System (Active Sentry) (734) and Centurion Vision System Accessory Ozil Torsional Handpiece (651).

Which device types does it report on?

unit, phacofragmentation (86.8%), laser, ophthalmic (3%), aberrometer, ophthalmic (2.8%) and instrument, vitreous aspiration and cutting, ac-powered (2.1%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.