Implant, eye valve: medical device reports filed with FDA

4,403 reports carry this product code, 1994–2026; 9 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.

4,403
reports with this product code: 0% of all MAUDE reports; 268
reports, 12 months to August 2026: 299 in the 12 months before; 30.3%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code KYF is FDA's classification for "Implant, eye valve" (ophthalmic panel), a class 2 device. 4,403 medical device reports carry this product code, 0% of the MAUDE database, from January 1994 to August 2026.

268 reports arrived in the 12 months to August 2026, down 10% from 299 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 (69.5%), malfunction (30.3%) and other (0.2%). 9 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
Xen 45 Gts	1,663	88	0%	35.8%
Ex-Press Glaucoma Filtration Device	666	11	0%	32.6%
Ex-Press Mini Glaucoma Shunt	552	0	0%	37.3%
Ahmed Glaucoma Valve	374	29	0%	26.5%
Baerveldt Shunt	345	14	0%	19.4%
Xen 45 Gts Australia	207	0	0%	8.2%
iStent Infinite Trabecular Micro-Bypass System	178	65	0%	30%
Istent Inject Trabecular Micro Bypass System	4	0	0%	26.3%
Istent Trabecular Micro-Bypass	1	0	0%	18.5%

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
Allergan Irvine	1,936	44%
Optonol	1,263	28.7%
Amo Manufacturing Netherlands	220	5%
Glaukos	184	4.2%
Johnson & Johnson Surgical Vision	152	3.5%
Abbott Medical Optics	93	2.1%
Allergan	8	0.2%
Alcon Research - Alcon Precision Device	3	0.1%
Staar Surgical	2	0%
Advanced Medical Optics	1	0%
Alcon Laboratories	1	0%
Alcon Research / Huntington	1	0%
Alcon Research /Huntington	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

Injury69.5%3,061

Malfunction30.3%1,332

Other0.2%7

Not given0.1%3

Who filed

Manufacturer report98.8%4,348

Voluntary report0.7%32

User facility report0%0

Distributor report0.1%4

Not given0.4%19

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

Device problems coded

Device problem (FDA code)	Reports	Share
Complete blockage	407	9.2%
Physical resistance/sticking	345	7.8%
Malposition of device	283	6.4%
Migrationthe device moved from where it was placed	151	3.4%
Mechanical jam	121	2.7%
Device appears to trigger rejection	112	2.5%
Device operates differently than expectedthe device behaved unexpectedly	112	2.5%
Fracturea broken bone	100	2.3%
Insufficient device problem information	95	2.2%
Breakthe device broke	93	2.1%
Device dislodged or dislocated	79	1.8%
Obstruction of flow	77	1.7%
No flow	74	1.7%
Failure to deliverthe device did not deliver the dose or item	68	1.5%
Partial blockage	58	1.3%
Material twisted/bent	55	1.2%
Occlusion within devicethe device blocked	34	0.8%
Retraction problem	33	0.7%
Defective devicethe device was defective	32	0.7%
Migration or expulsion of device	32	0.7%

Questions about implant, eye valve reports

What is product code KYF?

FDA's classification code for "Implant, eye valve", class 2, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

4,403 reports through August 2026, 268 of them in the latest 12 months.

Which brands appear most often?

Xen 45 Gts (1,663), Ex-Press Glaucoma Filtration Device (666), Ex-Press Mini Glaucoma Shunt (552), Ahmed Glaucoma Valve (374) and Baerveldt Shunt (345). 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.