MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-03-25 for VERION DIGITAL MARKER M X-SPM 8065998243 manufactured by Wavelight Gmbh (agps).
[5572979]
Surgeon reported to company representative a case of incorrect placement of incisions resulted in incorrect orientation of a toric intraocular lens (iol) in a patient's left eye. Reporter indicated a residual postoperative astigmatism occured, and the patient was returned to the operating room on the same day where the iol was rotated to the correct axial position. Reporter indicated the patient is doing well. Follow up information relayed user had missed the selection of physician orientation of the device to determine correct register of incisions.
Patient Sequence No: 1, Text Type: D, B5
[13117293]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[27242689]
Additional information provided: attempts have been made to obtain additional information; however, customer is unwilling to provide any additional information related to this event. No technical root cause could be determined as the system was performing within specifications. Contributing factors could be misuse of the device, the surgeon has to review and confirm surgical planning screen before the treatment. As per investigation, observed error in axis mapping due to wrong doctor position. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[27242690]
Attempts have been made to obtain additional information; however, customer is unwilling to provide any additional information related to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010300699-2015-00501 |
| MDR Report Key | 4633445 |
| Report Source | 01,05,07 |
| Date Received | 2015-03-25 |
| Date of Report | 2015-06-10 |
| Date of Event | 2015-02-10 |
| Date Mfgr Received | 2015-05-12 |
| Date Added to Maude | 2015-03-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152742 |
| 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 DIGITAL MARKER M |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2015-03-25 |
| Model Number | X-SPM |
| Catalog Number | 8065998243 |
| Lot Number | NA |
| ID Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Required No Informationntervention | 2015-03-25 |