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.