Instrument, vitreous aspiration and cutting, ac-powered: medical device reports filed with FDA

5,964 reports carry this product code, 1993–2026; 17 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.

5,964
reports with this product code: 0% of all MAUDE reports; 307
reports, 12 months to August 2026: 274 in the 12 months before; 56.3%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code HQE is FDA's classification for "Instrument, vitreous aspiration and cutting, ac-powered" (ophthalmic panel), a class 2 device. 5,964 medical device reports carry this product code, 0% of the MAUDE database, from August 1993 to August 2026.

307 reports arrived in the 12 months to August 2026, up 12% from 274 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 malfunction (56.3%), injury (42.3%) and other (1%). 17 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
Series Twenty Thousand Legacy	2,557	0	0%	36.7%
Laser Probes	512	27	0%	95.1%
Storz Premiere Ophthalmic Microsurgical Unit	365	0	0%	95.4%
HyperVit Vitrectomy Probe	336	221	0%	98.8%
Accurus 800cs	258	0	0%	79.3%
Backflush Handle DSP	233	43	0%	42.5%
Accurus 600ds	145	0	0%	61.3%
Accurus 400vs	123	0	0%	83%
Infiniti Vision System	52	0	0%	72.3%
Alcon	42	2	0%	36.7%
Millennium Microsurgical System	19	0	0%	53.3%
Series 20000 Legacy	11	0	0%	68.4%
Viscoat	7	0	0.5%	21.8%
Infiniti Vision System Ozil	2	0	0%	74.2%
M Series	2	4	2.3%	97.4%
Custom Pak	1	0	0%	74.1%
Storz Phacoemulsification Handpiece	1	0	0%	99.2%

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 - Irvine Technology Center	1,469	24.6%
Alcon Laboratories	1,306	21.9%
Alcon Research - Irvine Technology Center	483	8.1%
Storz Instrument	392	6.6%
Alcon Research - Houston	338	5.7%
Alcon Grieshaber	240	4%
Bausch & Lomb	239	4%
Bausch & Lomb Surgical	163	2.7%
Alcon - Irvine Technology Ctr	118	2%
Pt Ciba Vision Batam	22	0.4%
Bausch + Lomb	15	0.3%
Advanced Medical Optics	4	0.1%
Zoll Medical	2	0%
Lumenis	1	0%
Staar Surgical	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%2

Injury42.3%2,522

Malfunction56.3%3,355

Other1%62

Not given0.4%23

Who filed

Manufacturer report95.2%5,676

Voluntary report1.5%89

User facility report0%0

Distributor report0.1%4

Not given3.3%195

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device issuea problem with the device	609	10.2%
Replace	577	9.7%
Thermal decomposition of device	559	9.4%
Failure to cut	451	7.6%
Other (for use when an appropriate device code cannot be identified)	267	4.5%
Fitting problem	263	4.4%
Device displays incorrect message	238	4%
Particulates	150	2.5%
Loss of powerthe device lost power	143	2.4%
Suction problem	132	2.2%
Device inoperablethe device could not be used	129	2.2%
Aspiration, incomplete	114	1.9%
Difficult to insertthe device was hard to insert	111	1.9%
Failure, intermittent	104	1.7%
Malfunction	99	1.7%
Inability to irrigate	88	1.5%
Occlusion within devicethe device blocked	87	1.5%
Device, or device fragments remain in patient	81	1.4%
Device operational issue	76	1.3%
Repair	76	1.3%

Questions about instrument, vitreous aspiration and cutting, ac-powered reports

What is product code HQE?

FDA's classification code for "Instrument, vitreous aspiration and cutting, ac-powered", class 2, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,964 reports through August 2026, 307 of them in the latest 12 months.

Which brands appear most often?

Series Twenty Thousand Legacy (2,557), Laser Probes (512), Storz Premiere Ophthalmic Microsurgical Unit (365), HyperVit Vitrectomy Probe (336) and Accurus 800cs (258). 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.