Recall Z-1127-2015 ยท HQF Laser, Ophthalmic
Nidek Inc
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.
| Date | Feb 19, 2015 (initiated Mar 27, 2012) |
| Status | Terminated |
| Reason | The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself. |
| Root cause | Component design/selection |
| Action | Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction. |
| Quantity | 16 units in commerce |
| Distribution | Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110228 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR Nidek Incorporated, Feb 23, 2011 |