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 with the FDA on 2016-05-27 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).

Event Text Entries

[46163854] Evaluation summary: the device history records (dhr) for the device was reviewed. The associated device was released based on company acceptance criteria. 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


[46163855] A surgeon reported that following implantation of toric intraocular lenses (iols), the refractive outcomes have not been as expected. The surgeon explained that in 25 percent of his patients, the clinical outcome has been 90 degrees away from the predicted position calculated by the system. The surgeon believes the equipment may be flawed. The surgeon did not provide a specific number of cases or patients. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


[50521772] Evaluation summary: root cause: most likely identified as use error and additional training was performed. Actions taken: the surgeon mentor program was offered to the reporting surgeon. The sales team has been working closely with him regarding iol calculation and selection for qualifying candidates has been going very well. This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate. This will include completing reviews of complaint class report levels on a monthly basis. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3010300699-2016-00026
MDR Report Key5686335
Date Received2016-05-27
Date of Report2016-07-26
Date Mfgr Received2016-07-01
Device Manufacturer Date2014-09-11
Date Added to Maude2016-05-27
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 ContactMR. EDDIE DARTON, MD, JD
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175686660
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 Received2016-05-27
Model NumberX-RUS
Catalog Number8065998240
Lot NumberASKU
ID Number2.6
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 2016-05-27

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