U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Laser, ophthalmic - Product Code HQF
원인
The spot size control of the scan delivery unit of the mc-500 multicolor laser photocoagulator may turn by itself.
조치
Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.
Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
제품 설명
MC-500 Multicolor Laser Photocoagulator; || Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.