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2026 data FDA MAUDE openFDA FDA Class III

Gases Used Within Eye To Place Pressure On Detached Retina

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class III (highest risk, premarket approval required), regulated under 21 CFR §886.4270 (Ophthalmic panel).

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FDA MAUDE casebook

openFDA event book Gases Used Within Eye To Place Pressure On… LIGHT-BOOK · MAUDE

#888 of 1000 · 504 reports · 1997–2026

  • BOOK 504 reports
  • RANK #888 of 1000
  • DEATH 0 death-typed
  • INJ 280 injury-typed
  • MALF 206 malfunction
  • SPAN 1997–2026
  • PEAK 2022: 97
  • PHOTO Bone Grafting Material

Nearest event-volume peer: Bone Grafting Material, Synthetic (1 report gap)

Gases Used Within Eye To Place Pressure On Detached Retina sits #888 of 1000 among tracked device types with 504 MAUDE reports spanning 1997–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Gases Used Within Eye To Place Pressure On… carries 55.6% INJURY-coded reports, 25.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 55.6% corpus 30.3% · above corpus mean (+25.3 pp)
  • MALF 40.9% corpus 64.8% · below corpus mean (-24.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Lead manufacturer ALCON LABORATORIES, INC. accounts for 100% of manufacturer-tagged reports · Top event location is 72% of location-tagged rows .

Gases Used Within Eye To Place Pressure On… in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Gases Used Within Eye To Place Pressure On Detached Retina carries 504 MAUDE reports, ranked #888 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 280 (55.6%)
Malfunction 206 (40.9%)
Other 18 (3.6%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Other 184 (30.4%)
165 (27.3%)
Required Intervention 131 (21.7%)
R 54 (8.9%)
O 38 (6.3%)
Disability 17 (2.8%)
Hospitalization 7 (1.2%)
S 6 (1.0%)
H 3 (0.5%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 160
Gas Output Problem 42
Device Operates Differently Than Expected 32
Unknown (for use when the device problem is not known) 31
Appropriate Device Problem Term/Code Not Available 30
Failure to Deliver 25
Insufficient Device Problem Information 23
Other (for use when an appropriate device code cannot be identified) 19
No Flow 17
Use of Device Problem 17
Gas/Air Leak 9
Short Fill 9
Filling Problem 8
Material Disintegration 8
Mechanical Jam 7
Sticking 7
Therapeutic or Diagnostic Output Failure 6
Air Leak 5
Defective Component 5
Defective Device 5

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
26
2026: 11

Reports rose to 55 in 2025, up from an average of 17 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Gases Used Within Eye To Place Pressure On Detached Retina

Top Manufacturers

ALCON LABORATORIES, INC. 9

Event Locations

365 (72.4%)
I 122 (24.2%)
HOSPITAL 11 (2.2%)
NO INFORMATION 3 (0.6%)
UNKNOWN 2 (0.4%)
OTHER 1 (0.2%)

Nationwide devices with a comparable report-volume footprint

Gases Used Within Eye To Place Pressure On… carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (504 here).

Bone Grafting Material, Synthetic 505 Extracorporeal System For Long-Term Respira… 505 Stylet, Tracheal Tube 506 Bronchial Thermoplasty System 500

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Gases Used Within Eye To Place Pressure On… are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Gases Used Within Eye To Place Pressure On…; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.