Food & Drug Administration SAFETY COMMUNICATION

Increased Risk of Corneal Haze Associated with the Raindrop Near Vision Inlay: FDA Safety Communication

23 October 2018


People who have had surgery to implant the Raindrop Near Vision Inlay
Eye care providers
Medical Specialties:

Ophthalmology, Optometry


This notice is to alert eye care providers and patients already implanted with the device of the increased risk of corneal haze (a type of cloudiness in the cornea due to inflammation) associated with the device. The FDA is advising that eye care providers not implant Raindrop inlays and is working with Optics Medical to have all remaining product on the market recalled. Raindrop Inlays are no longer being distributed in the U.S.

Full FDA Safety Communication



Current and Resolved Drug Shortages and Discontinuations Reported to FDA

Leucovorin Calcium Lyophilized Powder for Injection
Status: Currently in Shortage
»Date first posted: No date available
»Therapeutic Categories: Oncology; Pediatric

Please note Levoleucovorin (Fusilev) is available in ample quantities. There is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev). The dose of levoleucovorin (Fusilev) is one-half the dose of racemic leucovorin injection (e.g., levoleucovorin [Fusilev] 7.5 mg = racemic leucovorin 15 mg). For more information visit the Spectrum Pharmaceuticals web site.

For full FDA shortages report