MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-12-08 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).
[32904986]
Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32904987]
A surgeon reported a case of a refractive outcome surprise three weeks post cataract procedure of the right eye. The reporter indicated the patient displayed an overcorrection of increased cylinder power, thereby increasing the astigmatism. The reporter stated the patient may require photo refractive keratectomy (prk) as intervention. Upon additional follow up, reporter indicated the patient experienced an unrelated cardiac event that required a hospital stay. Once the patient is released by the cardiologist, a lasek procedure will be scheduled.
Patient Sequence No: 1, Text Type: D, B5
[38463981]
Under the given conditions of an irregular cornea, an irregular cylinder with a difference of the measured steep axis of more than 30? And comparing 1mm to 4mm measurement zone, a crosscheck with alternative diagnostic devices/methods is recommended. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with irregular corneal astigmatism. No technical root cause could be determined as the system is performing within specifications. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2015-00520 |
| MDR Report Key | 5273818 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-12-08 |
| Date of Report | 2016-02-05 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2016-01-08 |
| Date Added to Maude | 2015-12-08 |
| 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. EDDIE DARTON, MD, JD |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal | 91058 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELOW BERLIN 14513 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14513 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERION REFERENCE UNIT |
| Generic Name | KERATOMETER, PUPILLOMETER |
| Product Code | HLG |
| Date Received | 2015-12-08 |
| Model Number | X-RUS |
| Catalog Number | 8065998240 |
| Lot Number | ASKU |
| ID Number | 00380659982408 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH (AGPS) |
| Manufacturer Address | RHEINSTRASSE 8 TELOW BERLIN 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-08 |