MedDRA preferred term

Cataract operation: adverse event reports recording this term

5,835 reports to FDA record it, 2004–2026; 0% of the database.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,835
reports recording the term: 0% of all reports; 379
reports, 12 months to June 2026: 423 in the 12 months before; 87.5%
marked serious by the reporter: 57.4% across all reports; 2.6%
record death among outcomes, as reported: 9.1% across all reports

"Cataract operation" is a MedDRA preferred term recorded in 5,835 adverse event reports received by FDA, 0% of the database, from February 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

379 reports recorded it in the 12 months to June 2026, down 10% from 423 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 87.5% are marked serious, 2.6% include death among the outcomes and 24.4% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Fosamax, Enbrel and Alendronate sodium. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Fosamax	Bisphosphonate	374	1.1%
Enbrel	Tumor necrosis factor blocker	336	0.1%
Alendronate sodium	Bisphosphonate	224	1.2%
Eylea	Vascular endothelial growth factor inhibitor	220	0.9%
Ozempic	GLP-1 receptor agonist	208	0.4%
Lantus Solostar	Insulin analog	142	0.3%
Xalatan	Prostaglandin analog	128	1.4%
Forteo	Parathyroid hormone analog	126	0.1%
Dupixent	Interleukin-4 receptor alpha antagonist	122	0%
Humira	—	105	0%
Prolia	RANK ligand inhibitor	105	0.1%
Abatacept	Selective T cell costimulation modulator	89	0.4%
Lantus	Insulin analog	89	0.2%
Advair Diskus	Corticosteroid	88	0.4%
Novolog	Insulin analog	73	0.5%
Certolizumab pegol	Tumor necrosis factor blocker	72	0.3%
Fosamax Plus D	—	70	2.9%
Xeljanz	Janus kinase inhibitor	70	0%
Remicade	Tumor necrosis factor blocker	69	0%
Advair Hfa	Corticosteroid	68	0.3%
Orencia	Selective T cell costimulation modulator	65	0.1%
Methotrexate	Folate analog metabolic inhibitor	63	0%
Cimzia	Tumor necrosis factor blocker	62	0.1%
Actemra	Interleukin-6 receptor antagonist	61	0.1%
Tresiba	Insulin analog	58	0.6%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Bisphosphonate	639	0.7%	0%
Tumor necrosis factor blocker	587	0.1%	0%
Insulin analog	500	0.2%	0.1%
Corticosteroid	386	0%	0%
GLP-1 receptor agonist	300	0.1%	0%
Vascular endothelial growth factor inhibitor	274	0.2%	0%
Prostaglandin analog	159	0.3%	0%
Selective T cell costimulation modulator	154	0.1%	0.3%
Interleukin-4 receptor alpha antagonist	128	0%	0%
Parathyroid hormone analog	126	0.1%	0.1%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.1%3

2 to 110.1%6

12 to 170.1%3

18 to 441%60

45 to 6413.5%787

65 to 7423.3%1,359

75 and over17.1%1,000

Age not given44.9%2,617

Patient sex

Female64.7%3,773

Male25.9%1,512

Not given9.4%550

Grey bar: all 20,646,523 reports in the database. 71.1% of these reports give the United States as the country.

Questions about "Cataract operation"

What does "Cataract operation" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record cataract operation?

5,835 reports through June 2026 (0% of all reports), 379 of them in the latest 12 months.

Which drugs appear most often in these reports?

Fosamax (374), Enbrel (336), Alendronate sodium (224), Eylea (220) and Ozempic (208). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.