MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for ORA SN6AT6 manufactured by Alcon Research, Llc.
[183884241]
Wrong lens measurement; near miss event related to adjustment with ora product - no injury to pt. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093775 |
| MDR Report Key | 9840160 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-28 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORA |
| Generic Name | ABERROMETER, OPHTHALMIC |
| Product Code | NCF |
| Date Received | 2020-03-16 |
| Model Number | ORA |
| Catalog Number | SN6AT6 |
| Lot Number | SN6AT6 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |