ALLEGRO OCULYZER 8065990641

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-05-01 for ALLEGRO OCULYZER 8065990641 manufactured by Wavelight Gmbh.

Event Text Entries

[3406110] A healthcare professional reported irregular images and measurements with system use. Per technical service representative the customer used another system to obtain a reliable measurement.
Patient Sequence No: 1, Text Type: D, B5


[10762178] 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 info becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003288808-2013-00209
MDR Report Key3109432
Report Source01,05
Date Received2013-05-01
Date of Report2013-04-03
Date Mfgr Received2013-04-03
Date Added to Maude2013-06-12
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 ContactARTHUR CIOCIOLA
Manufacturer Street6201 SOUTH FREEWAY, TC-40
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152442
Manufacturer G1WAVELIGHT GMBH
Manufacturer StreetAM WOLFSMANTEL 5
Manufacturer CityERLANGEN 91058
Manufacturer CountryGM
Manufacturer Postal Code91058
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameALLEGRO OCULYZER
Generic NameANTERIOR EYE SEGMENT ANALYSIS SYSTEM
Product CodeMXK
Date Received2013-05-01
Model Number8065990641
Catalog Number8065990641
Lot NumberNA
ID Number1.16R12
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerWAVELIGHT GMBH
Manufacturer AddressAM WOLFSMANTEL 5 ERLANGEN 91058 GM 91058


Patients

Patient NumberTreatmentOutcomeDate
10 2013-05-01

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