Voluntarily report to the FDA
Go to this FDA Link
- Click BEGIN on the right hand side of the screen.
- Complete section A and proceed to section B
- Write "TASS" in the event description under B5 of the MedWatch form and provide details of the adverse event.
- The manufacturer, trade names and lot numbers of any ophthalmic product (e.g., IOL, irrigating solution, viscoelastic, etc.) that is suspected to have caused TASS. If the suspected ophthalmic product is a drug, e.g., an irrigating solution, it should be included under "D. Suspect Product(s)" on the Med Watch form. If the suspected ophthalmic product is a device, e.g., a viscoelastic or an IOL, it should be included under "E. Suspect Medical Device" on the Med Watch form.
- The manufacturer and trade names of other ophthalmic products used during the surgical procedure (e.g., irrigation/aspiration tips, inserters, IOL cartridges, etc…) and the manufacturer and trade names of any anti-inflammatory agents used pre-operatively, operatively, or post-operatively. These should be included under "F. Other (Concomitant) Medical Products" on the Med Watch form.
- The results of any cultures taken.
- Any discoloration or abnormalities observed with products (e.g., clear product is discolored, potential contamination from the syringe coating, etc…)
- Summary conclusions of any internal investigation by the institution into the cause of the TASS case.
- Whether single use products were reused.