Amara View Amara View Mask with Headgear, Small, USRecalls & reported problems
Respironics, Inc. · Amara View Mask with Headgear, USA, Small · Class 2
Data updated Oct 18, 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 00606959009196), received between Jun 13, 2022 and Jun 13, 2022 — classified as 1 injury.
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
- Off-Label Use1
- Patient Device Interaction Problem1
- Use of Device Problem1
Patient problems
- Eye Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2022Off-Label Use; Use of Device Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Off-Label Use; Use of Device Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
THE MANUFACTURER WAS MADE AWARE OF AN ALLEGATION BY AN END USER THAT SHE DEVELOPED "CORNEAL EROSION" IN THE PAST 6 MONTHS DUE TO AIR BLOWING IN HER EYES DURING POSITIVE AIRWAY PRESSURE (PAP) THERAPY WHILE USING AN AMARA VIEW FACE MASK. THE USER WAS REPORTEDLY PRESCRIBED UNSPECIFIED EYE DROPS AND AN OINTMENT. THE USER HAS MODIFIED THE MASK BY DRILLING HOLES IN THE BOTTOM OF IT AND REFUSED THE MANUFACTURER'S REQUEST THAT SHE NOTIFY HER SUPPLIER. NO PART NUMBER OR LOT NUMBER HAVE BEEN PROVIDED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: Eye Injury
MAUDE report 14679035 ↗
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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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