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 05 report with the FDA on 2015-06-26 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).

Event Text Entries

[6041610] A nurse reported a case of a toric intraocular lens explanted, and indicated a diagnostic calculation error created an unexpected refractive out-come. Upon additional follow up, the reporter was unwilling to provide any additional information.
Patient Sequence No: 1, Text Type: D, B5


[13524925] 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


[26361897] No technical root cause could be determined, based on the information provided. Contributing factors for reported issue could be attributed to a poor diagnostic image, use of a non optimized formula during planning, or incorrect patient data entry. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3010300699-2015-00506
MDR Report Key4871813
Report Source05
Date Received2015-06-26
Date of Report2015-07-31
Date of Event2014-06-25
Date Mfgr Received2015-07-03
Date Added to Maude2015-06-26
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 FDA0
Event Location0
Manufacturer ContactMR. EDDIE DARTON, MD, JD
Manufacturer StreetAM WOLFSMANTEL 5
Manufacturer CityERLANGEN 91058
Manufacturer CountryGM
Manufacturer Postal91058
Manufacturer Phone8175686660
Manufacturer G1WAVELIGHT GMBH (AGPS)
Manufacturer StreetRHEINSTRASSE 8
Manufacturer CityTELOW BERLIN 14513
Manufacturer CountryGM
Manufacturer Postal Code14513
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameVERION REFERENCE UNIT
Generic NameKERATOMETER, PUPILLOMETER
Product CodeHJB
Date Received2015-06-26
Model NumberX-RUS
Catalog Number8065998240
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerWAVELIGHT GMBH (AGPS)
Manufacturer AddressRHEINSTRASSE 8 TELOW BERLIN 14513 GM 14513


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2015-06-26

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