Reported Reactions

Devices › Folders and injectors, intraocular lens (iol)

Device brand name · Intraocular lens delivery device

Easy Load Inserter: medical device reports filed with FDA

600 reports name it, 2006–2010. Manufacturer given most often on reports: Bausch & Lomb. Product code MSS.

600
device reports naming the brand
0% of all MAUDE reports · about 30 a year
0
reports, 12 months to August 2026
0 in the 12 months before
4.3%
classified as malfunction
61.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 600 reports that name the brand "Easy Load Inserter" (intraocular lens delivery device), received between May 2006 and November 2010; the manufacturer given most often on reports is Bausch & Lomb. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 (95%), malfunction (4.3%) and other (0.2%); across all folders and injectors, intraocular lens (iol) reports (product code MSS) death is recorded in 0% and malfunction in 61.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are haptic(s), bent (45.7%), lens replacement (18.3%) and failure to deliver (13.5%). The patient problems coded most often are surgical incision, enlargement of, lens, replacement of and foreign body, removal of. 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."

Reports by month, five years

No report naming Easy Load Inserter was received in the five years to August 2026; the latest was received in November 2010.

By year received

01302602006: 11220062007: 26020072008: 10820082009: 6220092010: 582010

Event type and report source

Event type, as classified on the report

Death0%0
Injury95%570
Malfunction4.3%26
Other0.2%1
Not given0.5%3

Who filed the report

Manufacturer report100%600
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 5,365 reports carrying product code MSS. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Haptic(s), bent27445.7%4.3%
Lens replacement11018.3%2.9%
Failure to deliverthe device did not deliver the dose or item8113.5%1.8%
Haptic damaged in delivery system6811.3%2.3%
Replace549%1.3%
Haptic(s), broken538.8%1.6%
Device, removal of (non-implant)396.5%1%
Implant, removal of396.5%1.1%
Device issuea problem with the device355.8%0.6%
Difficult to insertthe device was hard to insert335.5%1.5%
Lens damaged in delivery system325.3%2.9%
Lens stuck in delivery system213.5%0.6%
Other (for use when an appropriate device code cannot be identified)172.8%3%
Explanted152.5%0.7%
Device damaged prior to usethe device was damaged before use132.2%0.3%
Lens (iol), torn, split, cracked91.5%3.2%
Delivered as unsterile product81.3%0.1%
Difficult to position81.3%0.2%
Lens, malposition of61%0%
Malfunction61%0.1%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Surgical incision, enlargement of11919.8%
Lens, replacement of538.8%
Foreign body, removal of183%
Therapy/non-surgical treatment, additional162.7%
Vitrectomy152.5%
Capsular bag tear142.3%
Surgical procedure71.2%
Surgical procedure, additional61%
Eye injury40.7%
Surgical procedure, repeated40.7%
No patient involvement30.5%
Surgery, prolonged30.5%
Surgical procedure, delayed30.5%
Endophthalmitisinfection inside the eye10.2%
Hemorrhage/blood loss/bleeding10.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureEasy Load InserterProduct code MSSAll MAUDE reports
Reports6005,36526,136,888
Share of that pool—11.2%0%
Classified as death, per 1,000 reports009
Classified as injury95%37.8%36.2%
Classified as malfunction4.3%61.8%62.3%
Filed by the manufacturer100%98.9%94.9%

Shares are of reports, not 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."

Other brands with product code MSS

BrandReportsLatest 12 monthsClassified as death
Microstaar Injector93400%
Ez-28 Delivery System19700%
Microstaar Foam Tip Plunger25100%
MONARCH IOL Delivery System, Cartridge220260%
Microstaar Injector Cartridge62200%
Crystalens Accommodating Iol70100%
Soflex Silicone Square Edge Foldable Lens35300%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Easy Load Inserter reports

How many FDA reports name Easy Load Inserter?

600 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (95%), malfunction (4.3%) and other (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

haptic(s), bent (45.7%), lens replacement (18.3%), failure to deliver (13.5%), haptic damaged in delivery system (11.3%) and replace (9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Easy Load Inserter was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.