Folders and injectors, intraocular lens (iol): medical device reports filed with FDA

5,365 reports carry this product code, 1997–2026; 8 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.

5,365
reports with this product code: 0% of all MAUDE reports; 431
reports, 12 months to August 2026: 485 in the 12 months before; 61.8%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code MSS is FDA's classification for "Folders and injectors, intraocular lens (iol)" (ophthalmic panel), a class 1 device. 5,365 medical device reports carry this product code, 0% of the MAUDE database, from June 1997 to August 2026.

431 reports arrived in the 12 months to August 2026, down 11% from 485 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 (61.8%), injury (37.8%) and other (0.2%). 8 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
Easy Load Inserter	391	0	0%	4.3%
Microstaar Injector	298	0	0%	79.7%
Ez-28 Delivery System	197	0	0%	0.5%
Microstaar Foam Tip Plunger	171	0	0%	68.5%
MONARCH IOL Delivery System, Cartridge	123	26	0%	50.9%
Microstaar Injector Cartridge	98	0	0%	83.1%
Crystalens Accommodating Iol	1	0	0%	0.1%
Soflex Silicone Square Edge Foldable Lens	1	0	0%	66.3%

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 - Huntington	2,353	43.9%
Bausch & Lomb	855	15.9%
Bausch + Lomb	713	13.3%
Staar Surgical	630	11.7%
Alcon Research - Alcon Precision Device	443	8.3%
Rayner Intraocular Lenses	77	1.4%
Bausch & Lomb Surgical	58	1.1%
Rxsight	54	1%
Hoya Surgical Optics	4	0.1%
Johnson & Johnson Surgical Vision	4	0.1%
Alcon Laboratories	2	0%
Alcon Research / Huntington	2	0%
Alcon Research /Huntington	2	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

Injury37.8%2,027

Malfunction61.8%3,315

Other0.2%11

Not given0.2%12

Who filed

Manufacturer report98.9%5,305

Voluntary report0.4%24

User facility report0%0

Distributor report0.5%25

Not given0.2%11

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device damaged by another device	820	15.3%
Crackthe device cracked	429	8%
Device contamination with chemical or other material	407	7.6%
Scratched material	273	5.1%
Haptic(s), bent	233	4.3%
Breakthe device broke	223	4.2%
Material split, cut or torn	207	3.9%
Lens (iol), torn, split, cracked	174	3.2%
Other (for use when an appropriate device code cannot be identified)	160	3%
Lens replacement	157	2.9%
Lens damaged in delivery system	153	2.9%
Haptic damaged in delivery system	124	2.3%
Insufficient device problem information	112	2.1%
Plunger override	108	2%
Material twisted/bent	101	1.9%
Failure to deliverthe device did not deliver the dose or item	96	1.8%
Haptic(s), broken	88	1.6%
Defective component	86	1.6%
Defective devicethe device was defective	85	1.6%
Difficult to insertthe device was hard to insert	79	1.5%

Questions about folders and injectors, intraocular lens (iol) reports

What is product code MSS?

FDA's classification code for "Folders and injectors, intraocular lens (iol)", class 1, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,365 reports through August 2026, 431 of them in the latest 12 months.

Which brands appear most often?

Easy Load Inserter (391), Microstaar Injector (298), Ez-28 Delivery System (197), Microstaar Foam Tip Plunger (171) and MONARCH IOL Delivery System, Cartridge (123). 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.