MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-26 for VERION DIGITAL MARKER M X-SPM 8065998243 manufactured by Wavelight Gmbh (agps).
[78554874]
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
[78554875]
A doctor of ophthalmology reported during a patient's left eye cataract procedure, the image guided system was utilized. Toric lens was desired to be implanted. However, the image guided system located an axis approximately 10 - 15 degrees different than where the doctor had indicated his markings prior to surgery. The doctor opted to not use the image guided location and used his own. The doctor reported that the patient developed chemosis (irrigation solution accumulation under the conjunctiva and tissue swelling) during the operation. The doctor also stated that if he had implanted the lens based on the device's reliability, the patient's treatment of astigmatism would not have been successful.
Patient Sequence No: 1, Text Type: D, B5
[113535260]
No anomalies found by review of device history record. Product met all specifications when released. The root cause is the reference image of the patient used for registration is not appropriate according to the description in the user manual of the reference unit. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[113536468]
The eyelid covers a lot of the patients limbus and scleral vessel structures used for registration. Development of chemosis impacts the performance of the system as also outlined in the user manual of the digital marker which might led to the reported change of the displayed axis: bleedings and/or a bloated conjunctiva, due to anesthesia, may make it impossible to assist the surgeon in positioning the incisions or toric intraocular lens using the digital marker. Bleedings/ swelling: ensure that no heavy conjunctival hemorrhage or swelling is present. Heavy bleeding and swelling will affect the registration process. Clinical applications specialist (cas) explained to the surgeon and made a quick presentation of important practical steps of system. Everything seems to be fine now. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[115244194]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00015 |
| MDR Report Key | 6666743 |
| Date Received | 2017-06-26 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-05-31 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-06-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NADIA BAILEY |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW D-14513 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-14513 |
| Manufacturer Phone | 8176152230 |
| 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 | 0 |
| Brand Name | VERION DIGITAL MARKER M |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2017-06-26 |
| Model Number | X-SPM |
| Catalog Number | 8065998243 |
| Lot Number | 13662 |
| ID Number | 00380659982439 |
| Operator | PHYSICIAN |
| 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 TELTOW 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-26 |