🇺🇸 BSS Plus in United States

FDA authorised BSS Plus on 28 October 1981 · 454 US adverse-event reports

Marketing authorisation

FDA — authorised 28 October 1981

  • Application: NDA018469
  • Marketing authorisation holder: ALCON
  • Local brand name: BSS PLUS
  • Indication: SOLUTION — IRRIGATION
  • Status: approved

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Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Endophthalmitis — 126 reports (27.75%)
  2. Toxic Anterior Segment Syndrome — 70 reports (15.42%)
  3. Wrong Technique In Product Usage Process — 70 reports (15.42%)
  4. Corneal Oedema — 50 reports (11.01%)
  5. Corneal Opacity — 30 reports (6.61%)
  6. Macular Oedema — 26 reports (5.73%)
  7. Off Label Use — 22 reports (4.85%)
  8. Product Quality Issue — 21 reports (4.63%)
  9. Eye Inflammation — 20 reports (4.41%)
  10. Non-Infectious Endophthalmitis — 19 reports (4.19%)

Source database →

Other Ophthalmology approved in United States

Frequently asked questions

Is BSS Plus approved in United States?

Yes. FDA authorised it on 28 October 1981.

Who is the marketing authorisation holder for BSS Plus in United States?

ALCON holds the US marketing authorisation.