EyeMax2 R300P02Recalls & reported problems

Maxtec, LLC · Preemie 20/pack · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817770021834), received between Nov 17, 2020 and Nov 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.

Most reported problems

Device problems

Improper or Incorrect Procedure or Method1

Patient problems

Airway Obstruction1
Apnea1

Recent adverse event reports

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

InjuryNov 17, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ADVERSE EVENT REPORTED VIA EU MHRA MIR 2019/010/022/401/011: NARRATIVE FROM MHRA ADVERSE INCIDENT REPORT AS FILED BY NURSE: "WE HAD THREE INCIDENTS IN THE LAST 2 YEARS WHEN THE EYE GOGGLES HAVE SLIPPED DOWN, AND OBSTRUCTED THE INFANT'S NOSE AND MOUTH. THE FIRST TWO INCIDENTS APPEARED TO HAVE RESULTED IN AN INCREASE IN THE WORK OF BREATHING (INCLUDING STERNAL RECESSION). THIS THIRD INCIDENT THAT HAPPENED LAST WEEK ON INFANT WAS BORN AT (B)(6) WEEKS AND (B)(6) DAYS OLD ON ADMISSION AND THE EYEMAX2 PREEMIE CAUSED THE APNEA ALARM TO GO OFF. THE INFANT HAD SHALLOW BREATHING APPEARED TO RECOVER BUT 40 MINUTES LATER HAD A RESPIRATORY ARREST. WE CAN'T BE SURE THE TWO EVENTS ARE LINKED BUT IT IS A WORRYING COINCIDENCE. SINCE THE PREVIOUS INCIDENT WE HAVE ADDED AN HOURLY CHECKLIST THAT THE MASK IS IN THE CORRECTION POSITION AND ON EACH BASSINET THERE ARE INSTRUCTIONS ON THE FITTING AND APPLICATION OF THE MASK." MAXTEC INVESTIGATION: THE EYEMAX2 PHOTOTHERAPY EYE MASK IS INTENDED FOR NEONATAL EYE PROTECTION DURING PHOTOTHERAPY TREATMENT OF JAUNDICE. THE MASK IS A SINGLE PATIENT USE, ONE-PIECE WRAP-AROUND DESIGN WHICH HAS TWO ATTACHMENT POINTS THAT MAY BE ADJUSTED INDEPENDENTLY TO PREVENT UNWAN
Patient problems: Airway Obstruction; Apnea
MAUDE report 10856020 ↗

Device details

UDI-DI	`00817770021834`
Brand	EyeMax2
Model	R300P02
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	Feb 25, 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 R300P01-002
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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