EyeMax2 R300P01-002Recalls & reported problems

Maxtec, LLC · Mediprema Regular EyeMax2 20/Pack · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817770022039), received between Mar 10, 2021 and Mar 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
AS DESCRIBED BY THE CUSTOMER: FIRST OF ALL, WE RECEIVED A CUSTOMER COMPLAINT ABOUT YOUR EYEMAX PRODUCT (REGULAR). OUR CUSTOMERS FIND THAT THEIR EYEMAX (BATCH NUMBER: 044284-1) APPEARED TO BE MORE SLIPPERY THAN BEFORE. THEY NEED TO REPOSITION THEM REGULARLY AND EVEN TO MAKE IT HOLD BY OTHER MEANS. IT SEEMS TO BE CAUSED BY THE NEW MATERIAL. THEY ARE AFRAID FOR THE SAFETY OF THE BABY WITH THE RISK OF EYE BURNS. IT SEEMS THAT THEY ARE THINKING ABOUT REPORTING A VIGILANCE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11457394 ↗

Device details

UDI-DI	`00817770022039`
Brand	EyeMax2
Model	R300P01-002
Company	Maxtec, LLC
Product code	FOK · Pad, Neonatal Eye
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 14, 2019

Device type (GMDN): Phototherapy eye protector, reusable

A device worn to cover and protect the eyes of a patient or user from potentially harmful rays [e.g., ultraviolet (UV)] to which parts, or all, of their body is intentionally exposed during light therapy treatment. It will typically be designed as goggles, special spectacles, or a mechanical mask-like shield with properties to block or inhibit the transmission of rays to the eyes. It will come in a variety of sizes, e.g., premature infant, neonatal, child, and adult. This is a reusable device.

Other Pad, Neonatal Eye devices

EyeMax2 R300P02
Maxtec, LLC · Pad, Neonatal Eye
1 report

All Pad, Neonatal Eye devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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