Allergan, PLC, of Dublin, Ireland, recalled to consumer level specific lots of four of its eye products:
- Refresh Lacri-Lube 3.5g and 7g for dry eye
- Refresh P.M. 3.5g for dry eye
- FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g)
- Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g.
Allergan initiated this recall based on a number of customer complaints that reported a small black particle at the time of use. This black particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminum tube, and potentially introduced into the product. Twelve customers reported experiencing a foreign body in their eye. Two customers reported eye irritation. Two customers reported ocular discomfort. Two customers reported superficial eye injuries. One customer reported eye pain. One customer reported eye swelling. One customer reported blurred vision.
If a particle gets into the eye, potential adverse events may include eye pain, eye swelling, ocular discomfort, or eye irritation. The lot number and expiration date may be found on the bottom flap of the carton with the safety seal and on the crimp seal of the product tube.
See the Recall
See also Medical Law Perspectives, July 2014: Injuries Resulting From Laser Procedures: Risks for Physicians, Technicians, and Manufacturers
See also Medical Law Perspectives, March 2013: When Cataract Treatment Creates More Harm Than Cure: Malpractice Liability Issues
See the Medical Law Perspectives April 3, 2015, Blog: Contact Lens Not Subject to Recall But Manufactured in the Same Facility, and Having Same Material Defect, Could Not Be Basis for Manufacturer’s Liability