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 2016-03-09 for VERION DIGITAL MARKER M X-SPM 8065998242 manufactured by Wavelight Gmbh (agps).
[39933393]
A service visit was performed. 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. Additional information has been requested but not received. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39933394]
An ophthalmic surgeon reported that the implantation axis was noticed to be not correct in a pool of patients after cataract surgery with intraocular lens (iol) implant. For three of these patients, a secondary intervention was performed in order to correct the gap. Additional information has been requested but not received. This is one of three reports being filed for the same facility and event.
Patient Sequence No: 1, Text Type: D, B5
[49639728]
Evaluation summary: sample was not returned. Requested data not provided. No technical root cause could be determined based on the information that was provided. Contributing factors for reported event could be a changing of doctor/microscope position after confirmation of the registration or guidelines of an appropriate surgery image where not followed (e. G too low microscope illumination, zoom level of the microscope too high or too low or bad centration of the eye during the surgery). Most likely the root cause is use error. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2016-00011 |
| MDR Report Key | 5488388 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-03-09 |
| Date of Report | 2016-07-15 |
| Date Mfgr Received | 2016-07-01 |
| Device Manufacturer Date | 2013-10-23 |
| Date Added to Maude | 2016-03-09 |
| 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 | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW 14513 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14513 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERION DIGITAL MARKER M |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2016-03-09 |
| Model Number | X-SPM |
| Catalog Number | 8065998242 |
| Lot Number | NA |
| ID Number | 2.6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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; 2. Required No Informationntervention | 2016-03-09 |