PMWClass II
Strabismus Detection Device
Ophthalmic · 21 CFR 886.1342
For the automated detection of misalignment of the visual axes for prescription use only.
MDR events9All time
Recalls1All time
Registered firms2Currently listed
510(k) clearances1All time
Recent MDR events
9 adverse event reports on file
- BLINQ PEDIATRIC VISION SCANNERJan 8, 2024MalfunctionRebiscan, Inc.3014522421-2022-00001
- BLINQ PEDIATRIC VISION SCANNERJan 6, 2024MalfunctionRebiscan, Inc.3014522421-2022-00002
- BLINQ PEDIATRIC VISION SCANNERJan 3, 2024MalfunctionRebiscan, Inc.3014522421-2022-00006
- BLINQ PEDIATRIC VISION SCANNERJan 3, 2024MalfunctionRebiscan, Inc.3014522421-2022-00009
- BLINQ PEDIATRIC VISION SCANNERJan 3, 2024MalfunctionRebiscan, Inc.3014522421-2022-00003
- BLINQ PEDIATRIC VISION SCANNERJan 3, 2024MalfunctionRebiscan, Inc.3014522421-2022-00008
- BLINQ PEDIATRIC VISION SCANNERJan 3, 2024MalfunctionRebiscan, Inc.3014522421-2022-00005
- BLINQ PEDIATRIC VISION SCANNERJan 3, 2024MalfunctionRebiscan, Inc.3014522421-2022-00004
- BLINQ PEDIATRIC VISION SCANNERJan 3, 2024MalfunctionRebiscan, Inc.3014522421-2022-00007
Event type breakdown
Malfunction9
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
2 firms currently registered for this product code
510(k) clearances
1 clearances for this product code