2026 data FDA MAUDE openFDA FDA Class I

Forceps, Ophthalmic

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §886.4350 (Ophthalmic panel).

FDA MAUDE casebook

openFDA event book Forceps, Ophthalmic LIGHT-BOOK · MAUDE

#707 of 1000 · 861 reports · 1992–2026

  • BOOK 861 reports
  • RANK #707 of 1000
  • DEATH 0 death-typed
  • INJ 128 injury-typed
  • MALF 728 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 135
  • PHOTO Clamp, Circumcision

Nearest event-volume peer: Clamp, Circumcision (1 report gap)

Forceps, Ophthalmic sits #707 of 1000 among tracked device types with 861 MAUDE reports spanning 1992–2026. 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 →

Malfunction reports run above the device-type norm

Forceps, Ophthalmic carries 84.6% MALFUNCTION-coded reports, 19.7pp 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 14.9% corpus 30.3% · below corpus mean (-15.4 pp)
  • MALF 84.6% corpus 64.8% · above corpus mean (+19.7 pp)

Lead product-problem code Difficult to Open or Close is 49% of coded problems · Lead manufacturer BAUSCH + LOMB accounts for 72% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Forceps, Ophthalmic in the event-volume neighbourhood

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

reports

What this shows Forceps, Ophthalmic carries 861 MAUDE reports, ranked #707 of 1000.

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

Event Types

Malfunction 728 (84.6%)
Injury 128 (14.9%)
3 (0.3%)
Other 2 (0.2%)

Patient Outcomes

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

691 (77.4%)
Other 98 (11.0%)
Required Intervention 57 (6.4%)
O 19 (2.1%)
H 11 (1.2%)
R 9 (1.0%)
Hospitalization 4 (0.4%)
Disability 3 (0.3%)
Invalid Data 1 (0.1%)

Top Product Problems

Difficult to Open or Close 393
Break 137
Adverse Event Without Identified Device or Use Problem 72
Activation Problem 54
Mechanical Jam 29
Physical Resistance/Sticking 21
Material Fragmentation 15
Tip breakage 13
Activation Failure 9
Mechanical Problem 9
Particulates 9
Device-Device Incompatibility 7
Device Dislodged or Dislocated 6
Fitting Problem 6
Sticking 6
Appropriate Device Problem Term/Code Not Available 5
Defective Device 5
Device Operates Differently Than Expected 5
Sharp/jagged/rough/etched/scratched 5
Component Missing 4

Yearly Trend

92
1992: 1
94
1994: 3
95
1995: 1
96
1996: 6
97
1997: 10
98
1998: 7
99
1999: 3
00
2000: 1
02
2002: 1
03
2003: 5
04
2004: 6
05
2005: 1
06
2006: 1
07
2007: 3
08
2008: 4
09
2009: 2
10
2010: 3
11
2011: 3
12
2012: 3
13
2013: 5
14
2014: 21
15
2015: 9
16
2016: 14
17
2017: 18
18
2018: 39
19
2019: 82
20
2020: 135
21
2021: 63
22
2022: 58
23
2023: 98
24
2024: 81
25
2025: 115
26
2026: 59

Reports in 2025 (115) held close to the prior two-year average of 90.

Related Entities for Forceps, Ophthalmic

Event Locations

486 (56.4%)
I 324 (37.6%)
HOSPITAL 31 (3.6%)
NO INFORMATION 7 (0.8%)
OUTPATIENT TREATMENT FACILITY 5 (0.6%)
AMBULATORY SURGICAL FACILITY 2 (0.2%)
INVALID DATA 2 (0.2%)
OTHER 2 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare BAUSCH + LOMB vs ALCON LABORATORIES, INC. →

Nationwide devices with a comparable report-volume footprint

Forceps, Ophthalmic 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 (861 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Forceps, Ophthalmic 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 Forceps, Ophthalmic; 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.