VERION REFERENCE UNIT X-RUS 8065998240

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-05-03 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).

Event Text Entries

[143966543] 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


[143966544] A facility representative reported incorrect keratometry readings were provided by the device which led to incorrect intraocular lens power being implanted. The patient complained of blurred vision. The intraocular lens was explanted. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010300699-2019-00006
MDR Report Key8577728
Report SourceOTHER
Date Received2019-05-03
Date of Report2019-06-27
Date Mfgr Received2019-06-06
Date Added to Maude2019-05-03
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 Report3

Device Details

Brand NameVERION REFERENCE UNIT
Generic NameKERATOMETER, PUPILLOMETER
Product CodeHLG
Date Received2019-05-03
Model NumberX-RUS
Catalog Number8065998240
Lot NumberASKU
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. Required No Informationntervention 2019-05-03

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