Device, irrigation, ocular surgery: medical device reports filed with FDA

2,149 reports carry this product code, 1994–2026; 2 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.

2,149
reports with this product code: 0% of all MAUDE reports; 78
reports, 12 months to August 2026: 83 in the 12 months before; 74.2%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code KYG is FDA's classification for "Device, irrigation, ocular surgery" (ophthalmic panel), a class 1 device. 2,149 medical device reports carry this product code, 0% of the MAUDE database, from June 1994 to August 2026.

78 reports arrived in the 12 months to August 2026, close to the 83 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 (74.2%), injury (25.4%) and other (0.3%). 2 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
Custom Pak	1,165	0	0%	74.1%
Disposable Polymer Irrigation and Silicone Irrigation and Aspiration Tips	209	44	0%	63.2%

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 - Alcon Precision Device	300	14%
Bausch & Lomb	151	7%
Bausch & Lomb Surgical	72	3.4%
Alcon - Irvine Technology Center	27	1.3%
Alcon Laboratories	25	1.2%
Amo Manufacturing USA	12	0.6%
Advanced Medical Optics	7	0.3%
Alcon Grieshaber	6	0.3%
Storz Instrument	5	0.2%
Alcon - Irvine Technology Ctr	3	0.1%
Alcon Research - Houston	3	0.1%
Alcon Research / Huntington	1	0%
Allergan	1	0%
Amo Puerto Rico Mfg	1	0%
Becton Dickinson And	1	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

Injury25.4%545

Malfunction74.2%1,594

Other0.3%6

Not given0.2%4

Who filed

Manufacturer report96.7%2,079

Voluntary report1.1%24

User facility report0%0

Distributor report0.1%2

Not given2%44

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

Device problems coded

Device problem (FDA code)	Reports	Share
Dull, blunt	295	13.7%
Failure to cut	197	9.2%
Device contamination with chemical or other material	183	8.5%
Fitting problem	97	4.5%
Device issuea problem with the device	95	4.4%
Breakthe device broke	78	3.6%
Foreign material	70	3.3%
Particulates	57	2.7%
Fluid/blood leak	56	2.6%
Suction failure	52	2.4%
Disconnection	47	2.2%
Material twisted/bent	38	1.8%
Replace	38	1.8%
Detachment of device component	35	1.6%
Connection problema connection problem	31	1.4%
Sharp edges	30	1.4%
Detachment of device or device componentpart of the device came off	26	1.2%
Obstruction of flow	23	1.1%
Device operates differently than expectedthe device behaved unexpectedly	22	1%
Complete blockage	21	1%

Questions about device, irrigation, ocular surgery reports

What is product code KYG?

FDA's classification code for "Device, irrigation, ocular surgery", class 1, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,149 reports through August 2026, 78 of them in the latest 12 months.

Which brands appear most often?

Custom Pak (1,165) and Disposable Polymer Irrigation and Silicone Irrigation and Aspiration Tips (209). 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.