VERION DIGITAL MARKER M X-SPM 8065998244

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-10 for VERION DIGITAL MARKER M X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).

Event Text Entries

[57471103] Additional information has been requested. No anomalies found by review of device history record, product met all specifications when released. Reported event resulted from the failure of the customer to follow published instructions for use. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[57471104] An ophthalmologist reported that one day following toric intraocular lens (iol) implant surgery in the left eye, the patient presented with an unplanned lens rotation. The target axis of the iol was at 170 degrees, but instead, it was at 10 degrees. The surgeon is concerned that the positioning system provided incorrect axis placement. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


[63299567] No anomalies found by review of device history record, product met all specifications when released. A wrong registration proposal was confirmed by the user. Reported event resulted from the failure of the customer to follow published instructions for use. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3010300699-2016-00046
MDR Report Key6013949
Date Received2016-10-10
Date of Report2016-12-22
Date of Event2016-08-15
Date Mfgr Received2016-12-03
Date Added to Maude2016-10-10
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. RITA LOPEZ
Manufacturer StreetAM WOLFSMANTEL 5
Manufacturer CityERLANGEN 91058
Manufacturer CountryGM
Manufacturer Postal91058
Manufacturer Phone8175514846
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 Received2016-10-10
Model NumberX-SPM
Catalog Number8065998244
Lot NumberASKU
ID Number00380659982446
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2016-10-10

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