VERION DIGITAL MARKER M X-SPM 8065998242

MAUDE Adverse Event Report

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 2017-07-31 for VERION DIGITAL MARKER M X-SPM 8065998242 manufactured by Wavelight Gmbh (agps).

Event Text Entries

[81367649] 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


[81367650] A doctor reported that a green flash from the optic of the microscope dazzled his eyes. The surgeon was performing a toric intraocular lens implant procedure when this occurred. During the surgery, the imaging system bugged. The green flash dazzled the surgeon. The surgeon shouted and experienced discomfort and a white veil appeared in front of his eyes. The incident lasted about 30 seconds. The surgeon was about to finish the surgery he was performing. Surgeon is concerned about potential sequela following the flash. Upon follow up, glare was reported to have lasted about four minutes. Surgeon was afraid of losing part of his vision. There are two related reports for this patient. This report addresses the patient's right eye and another manufacturer report will be filed for the fellow eye.
Patient Sequence No: 1, Text Type: D, B5


[113538392] No anomalies found by review of device history record. Product met all specifications when released. At the visit on site, the field service engineer could not reproduce the error. Fse tried by himself during testing and confirms that the microscope integrated display (mid) behaves just like any other mid. Little green light at start up but nothing very intensive. Tuning control/check: test in accordance with the procedure. Control according to procedure-device in keeping with the company specifications. (b)(4)
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3010300699-2017-00021
MDR Report Key6753297
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-07-31
Date of Report2017-09-15
Date of Event2017-07-06
Date Mfgr Received2017-08-23
Date Added to Maude2017-07-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. NADIA BAILEY
Manufacturer StreetRHEINSTRASSE 8
Manufacturer CityTELTOW D-14513
Manufacturer CountryGM
Manufacturer PostalD-14513
Manufacturer Phone8176152230
Manufacturer G1WAVELIGHT GMBH (AGPS)
Manufacturer StreetRHEINSTRASSE 8
Manufacturer CityTELTOW 14513
Manufacturer CountryGM
Manufacturer Postal Code14513
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameVERION DIGITAL MARKER M
Generic NameMARKER, OCULAR
Product CodeFTH
Date Received2017-07-31
Model NumberX-SPM
Catalog Number8065998242
Lot NumberASKU
ID Number00380659982422
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWAVELIGHT GMBH (AGPS)
Manufacturer AddressRHEINSTRASSE 8 TELTOW 14513 GM 14513


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-07-31

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