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Gases Used Within Eye To Place Pressure On Detached Retina

Open-data reference.

FDA MAUDE adverse event data · 1997–2025

What the Data Shows About Gases Used Within Eye To Place Pressure On Detached Retina

The FDA MAUDE database aggregates 493 adverse-event reports for Gases Used Within Eye To Place Pressure On Detached Retina spanning the period from 1997 through 2025. Of these, 0 are classified as death reports, 269 as injury reports, and 206 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 3 distinct event types and 9 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Adverse Event Without Identified Device or Use Problem topping the list at 142 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 27 years of MAUDE data, with the peak single-year volume reaching 97 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 6 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

493
Total Reports
0
Death Reports
269
Injury Reports
206
Malfunctions

Event Types

Injury 269 (54.6%)
Malfunction 206 (41.8%)
Other 18 (3.7%)

Patient Outcomes

Other 173 (29.1%)
165 (27.8%)
Required Intervention 131 (22.1%)
R 54 (9.1%)
O 38 (6.4%)
Disability 17 (2.9%)
Hospitalization 7 (1.2%)
S 6 (1.0%)
H 3 (0.5%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 142
Gas Output Problem 40
Appropriate Term/Code Not Available 21
Failure to Deliver 20
No Flow 16
Device Operates Differently Than Expected 13
Gas/Air Leak 8
Short Fill 8
Insufficient Information 7
Filling Problem 6
Therapeutic or Diagnostic Output Failure 6
Device Inoperable 4
Air Leak 3
Defective Device 3
Unexpected Therapeutic Results 3
Complete Blockage 2
Defective Component 2
Mechanical Problem 2
Off-Label Use 2
Output Problem 2

Yearly Trend

97
1997: 4
98
1998: 1
00
2000: 6
01
2001: 9
02
2002: 6
03
2003: 2
05
2005: 11
06
2006: 11
07
2007: 4
08
2008: 19
09
2009: 13
10
2010: 24
11
2011: 17
12
2012: 16
13
2013: 22
14
2014: 9
15
2015: 10
16
2016: 15
17
2017: 21
18
2018: 22
19
2019: 29
20
2020: 18
21
2021: 18
22
2022: 97
23
2023: 25
24
2024: 9
25
2025: 55

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.