Bss
balanced salt solution · Solution · Ophthalmic
Uses
For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.
Dosage and administration
The adapter plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the DROP-TAINER ® bottle as explained below. External irrigation may be done without the irrigating needle. Method of using Adapter Plug for LUER-LOK ® Hub Ophthalmic Irrigating Needle: 1. Aseptically remove DROP-TAINER bottle from blister by peeling paper backing. 2. Snap on surgeon's sterile irrigation needle. Push until firmly in place and twist slightly. 3. Test assembly for proper function before use. NOTE: LUER-LOK is a registered trademark of Becton, Dickinson and Company.
Warnings
• NOT FOR INJECTION OR INTRAVENOUS INFUSION.
• Do not use unless product is clear, seal is intact, and container is undamaged.
• Do not use if product is discolored or contains a precipitate.
• SINGLE patient use only. The contents of this bottle should not be used in more than one patient.
• This solution contains no preservative, unused contents should be discarded.
Precautions
Open under aseptic conditions only. Prior to use, check the following: tip should be firmly in place, irrigating needle should be properly seated; squeeze out several drops before inserting into anterior chamber. The needle should be removed from the anterior chamber prior to releasing pressure to prevent suction. Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed. There have been reports of corneal clouding or edema following ocular surgery in which BSS Sterile Irrigating Solution was used as an irrigating solution.
Side effects
Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.
Description
DESCRIPTION BSS™ Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl 2
• 2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2
• 6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2
• 3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7
• 2H 2 O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.
How supplied
In 15 mL and 30 mL sterile DROP-TAINER bottles (consisting of a polypropylene bottle and LEUR-LOK ™ adapter plug with a white polypropylene closure) in a blister package. 15 mL in a 15 mL bottle: NDC 0065-0795-15 30 mL in a 30 mL bottle: NDC 0065-0795-30 STORAGE: Store at 36° - 77°F (2° - 25°C). Revised: May 2021 Alcon Distributed by: Alcon Laboratories , Inc. 6201 South Freeway Fort Worth, Texas 76134 USA © 2021 Alcon Inc. W300048945-0521
Label text from the FDA structured product label by Alcon Laboratories, Inc. (revised Jan 25, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Chloride in 2 products
- Potassium Chloride in 2 products
- Calcium Chloride in 2 products
- Magnesium Chloride in 2 products
- Sodium Acetate in 2 products
- Sodium Citrate in 2 products
Bss NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0065-0795 | Sodium Chloride 6.4 mg/mL; Potassium Chloride .75 mg/mL; Calcium Chloride .48 mg/mL; Magnesium Chloride .3 mg/mL;… Solution | Alcon Laboratories, Inc. | NDA |
| 0065-1795 | Sodium Chloride 6.4 mg/mL; Potassium Chloride .75 mg/mL; Calcium Chloride .48 mg/mL; Magnesium Chloride .3 mg/mL;… Solution | Alcon Laboratories, Inc. | NDA |
Bss recalls
- D-1033-2022 Jun 15, 2022 · Class II · Terminated
cGMP deviations: Temperature abuse - D-1034-2022 Jun 15, 2022 · Class II · Terminated
cGMP deviations: Temperature abuse
Frequently asked questions
What is Bss used for?
For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.
What are the side effects of Bss?
Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported. See the full label for the complete list.
Who makes Bss?
Bss is listed by 1 labeler in the FDA NDC directory, including Alcon Laboratories, Inc..
Has Bss been recalled?
The FDA enforcement database lists 2 recalls for Bss, most recently D-1033-2022 (class ii): cGMP deviations: Temperature abuse