Device manufacturer, as written on reports

Abbott Medical Optics: medical device reports filed with FDA

18,323 reports name it as the manufacturer of the device involved, 2009–2018.

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.

18,323
reports naming it as manufacturer: 0.1% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 38%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

18,323 medical device reports received by FDA give Abbott Medical Optics as the manufacturer of the device involved, 0.1% of the MAUDE database, from March 2009 to December 2018. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 (61.7%), malfunction (38%) and other (0.2%). 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
Intralase	Keratome, ac-powered	3,202	0	0%
Intralase Fs2	Keratome, ac-powered	2,183	9	0%
Tecnis	Intraocular lens	1,984	0	0.1%
Tecnis 1-Piece	Intraocular lens	1,479	0	0%
Tecnis 1 Multifocal	Lens, multifocal intraocular	1,426	0	0%
Tecnis Itec Preloaded 1-Piece Iol	Intraocular lens	1,246	0	0%
Whitestar Signature System	Unit, phacofragmentation	692	0	0%
Tecnis Cl	Intraocular lens	655	0	0%
Tecnis Symfony	Extended depth of focus intraocular lens	615	0	0%
Tecnis Symfony Toric	Extended depth of focus intraocular lens	386	0	0%
Sensar	Intraocular lens	377	0	0%
Platinum 1 Series	Lens, guide, intraocular	302	0	0%
Star	Excimer laser system	297	50	0%
Catalys System	Ophthalmic femtosecond laser	290	67	0%
Tecnis Multifocal	Lens, multifocal intraocular	209	0	0%
Ifs	Keratome, ac-powered	208	23	0%
Tecnis Optiblue Itec Preloaded 1-Piece Iol	Intraocular lens	195	0	0%
Ellips Fx Phaco Handpiece	Unit, phacofragmentation	179	8	0%
Healon	Aid, surgical, viscoelastic	150	0	0.4%
Emerald	Lens, guide, intraocular	146	10	0%
S4-Ir-Etl	Excimer laser system	130	0	0%
Baerveldt Shunt	Implant, eye valve	107	14	0%
Rezoom	Intraocular lens	57	0	0%
Tecnis Iol	Intraocular lens	4	715	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
HQL	Intraocular lens	6,063	33.1%
HNO	Keratome, ac-powered	5,750	31.4%
MFK	Lens, multifocal intraocular	1,998	10.9%
HQC	Unit, phacofragmentation	1,258	6.9%
POE	Extended depth of focus intraocular lens	1,002	5.5%
LZS	Excimer laser system	677	3.7%
KYB	Lens, guide, intraocular	545	3%
LPN	Accessories, soft lens products	320	1.7%
OOE	Ophthalmic femtosecond laser	295	1.6%
LZP	Aid, surgical, viscoelastic	189	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%1

Injury61.7%11,300

Malfunction38%6,970

Other0.2%33

Not given0.1%19

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

Questions about Abbott Medical Optics reports

How many FDA device reports name Abbott Medical Optics as manufacturer?

18,323 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Intralase (3,202), Intralase Fs2 (2,183), Tecnis (1,984), Tecnis 1-Piece (1,479) and Tecnis 1 Multifocal (1,426).

Which device types does it report on?

intraocular lens (33.1%), keratome, ac-powered (31.4%), lens, multifocal intraocular (10.9%) and unit, phacofragmentation (6.9%).

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.