MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-27 for KR-800S manufactured by Topcon.
[101266721]
I am an eyecare professional, i used the topcon kr-800s autorefractor with glare testing in my practice. The glare testing which is used to justify cataract surgery, and (b)(4) reimbursement is very inconsistent and inaccurate. I think the fda needs to investigate this since there are eye drs performing surgeries based on this instrument. The instrument is manufactured by topcon medical systems and distributed by (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075558 |
| MDR Report Key | 7302342 |
| Date Received | 2018-02-27 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-02-23 |
| Date Added to Maude | 2018-02-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | KR-800S |
| Generic Name | REFRACTOMETER, OPHTHALMIC |
| Product Code | HKO |
| Date Received | 2018-02-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOPCON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-27 |