VERION DIGITAL MARKER M X-SPM-03 8065998270

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for VERION DIGITAL MARKER M X-SPM-03 8065998270 manufactured by Wavelight Gmbh (agps).

Event Text Entries

[138939673] 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


[138939674] A nurse reported that the system axis alignment would change after lens was implanted on two back to back patients. System would be set at a number and the physical line would move to a different angle but still say the number that was set.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010300699-2019-00004
MDR Report Key8416023
Date Received2019-03-13
Date of Report2019-08-02
Date of Event2019-02-19
Date Mfgr Received2019-07-25
Date Added to Maude2019-03-13
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. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
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 Report0

Device Details

Brand NameVERION DIGITAL MARKER M
Generic NameMARKER, OCULAR
Product CodeHLG
Date Received2019-03-13
Model NumberX-SPM-03
Catalog Number8065998270
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerWAVELIGHT GMBH (AGPS)
Manufacturer AddressRHEINSTRASSE 8 TELTOW 14513 GM 14513


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-13

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