MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-10 for TOPCON VERSION 3.03 manufactured by Topcon Medical Systems, Inc..
[64931008]
Status update: investigation (topcon) topcon provided an updated status regarding the ongoing investigation into the misplaced patient exam data record. The final list of exam records impacted was 6. All of the impacted records have been staled (hidden) within synergy so that there is no chance of confusion moving forward. The list of impacted patients was provided to opp. The root cause of the issue (a setting that had been changed in the lenstar) has been corrected (the setting was changed back to its original value) and there is no further risk of misfiled patient records. Opp has been instructed to communicate and device configuration changes to the topcon technical support team so that they can verify the correct functioning of the data harvest process into synergy.
Patient Sequence No: 1, Text Type: N, H10
[64931009]
A patient's diagnostic report with name and demographics detail ended up in another patient's chart. When the chart was pulled for cataract surgery lens calculations, the wrong report appeared. The report name and demographics were not noticed and the wrong calculations were made to chose an interocular lens for surgery. The issue was noticed when the doctor was trying to figure out why the post-operative results were so unexpected. This could have require a second (unnecessary) operation for this patient to exchange the intraocular lens for the correct one, but did not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000307022-2017-00001 |
| MDR Report Key | 6239180 |
| Date Received | 2017-01-10 |
| Date of Report | 2017-01-10 |
| Date of Event | 2016-12-09 |
| Date Mfgr Received | 2017-12-12 |
| Date Added to Maude | 2017-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES LORKOWSKI |
| Manufacturer Street | 111 BAUER DR. |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal | 07436 |
| Manufacturer Phone | 2015995187 |
| Manufacturer G1 | TOPCON MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 111 BAUER DR. |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TOPCON |
| Generic Name | SYNERGY |
| Product Code | NFJ |
| Date Received | 2017-01-10 |
| Model Number | VERSION 3.03 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOPCON MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 111 BAUER DR. OAKLAND NJ 07436 US 07436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-10 |