Device manufacturer, as written on reports

Johnson & Johnson Surgical Vision: medical device reports filed with FDA

11,376 reports name it as the manufacturer of the device involved, 2018–2026.

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.

11,376
reports naming it as manufacturer: 0% of all MAUDE reports; 160
reports, 12 months to August 2026: 138 in the 12 months before; 36%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

11,376 medical device reports received by FDA give Johnson & Johnson Surgical Vision as the manufacturer of the device involved, 0% of the MAUDE database, from February 2018 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

160 reports arrived in the 12 months to August 2026, up 16% from 138 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 (63.9%) and malfunction (36%). 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 Fs2	Keratome, ac-powered	1,406	9	0%
Intralase	Keratome, ac-powered	1,259	0	0%
Tecnis Itec Preloaded 1-Piece Iol	Intraocular lens	1,012	0	0%
Tecnis	Intraocular lens	926	0	0.1%
Tecnis Symfony	Extended depth of focus intraocular lens	925	0	0%
Tecnis 1-Piece	Intraocular lens	668	0	0%
Tecnis Symfony Toric	Extended depth of focus intraocular lens	667	0	0%
Tecnis 1 Multifocal	Lens, multifocal intraocular	468	0	0%
Ifs	Keratome, ac-powered	318	23	0%
Catalys System	Ophthalmic femtosecond laser	312	67	0%
Sensar	Intraocular lens	279	0	0%
Laminar	Unit, phacofragmentation	224	13	0%
Platinum 1 Series	Lens, guide, intraocular	207	0	0%
Tecnis Cl	Intraocular lens	207	0	0%
Tecnis Optiblue Itec Preloaded 1-Piece Iol	Intraocular lens	169	0	0%
Baerveldt Shunt	Implant, eye valve	151	14	0%
Star	Excimer laser system	148	50	0%
Emerald	Lens, guide, intraocular	101	10	0%
Ellips Fx Phaco Handpiece	Unit, phacofragmentation	60	8	0%
FS Disposable Interface	Powered laser surgical instrument	56	116	0%
S4-Ir-Etl	Excimer laser system	51	0	0%
Whitestar Signature System	Unit, phacofragmentation	44	0	0%
Healon	Aid, surgical, viscoelastic	33	0	0.4%
Tecnis Iol	Intraocular lens	33	715	0%
Tecnis Simplicity	Intraocular lens	11	1,217	0%
Sensar Iol	Intraocular lens	1	232	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	3,473	30.5%
HNO	Keratome, ac-powered	3,038	26.7%
POE	Extended depth of focus intraocular lens	1,614	14.2%
HQC	Unit, phacofragmentation	961	8.4%
MFK	Lens, multifocal intraocular	663	5.8%
KYB	Lens, guide, intraocular	398	3.5%
OOE	Ophthalmic femtosecond laser	369	3.2%
LZS	Excimer laser system	264	2.3%
LZP	Aid, surgical, viscoelastic	246	2.2%
KYF	Implant, eye valve	152	1.3%

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

Injury63.9%7,273

Malfunction36%4,098

Other0%3

Not given0%1

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

Questions about Johnson & Johnson Surgical Vision reports

How many FDA device reports name Johnson & Johnson Surgical Vision as manufacturer?

11,376 reports through August 2026, 160 of them in the latest 12 months.

Which of its brands appear most often?

Intralase Fs2 (1,406), Intralase (1,259), Tecnis Itec Preloaded 1-Piece Iol (1,012), Tecnis (926) and Tecnis Symfony (925).

Which device types does it report on?

intraocular lens (30.5%), keratome, ac-powered (26.7%), extended depth of focus intraocular lens (14.2%) and unit, phacofragmentation (8.4%).

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.