ALLEGRO OCULYZER 8065990641

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for ALLEGRO OCULYZER 8065990641 manufactured by Wavelight Gmbh.

Event Text Entries

[90676519] 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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[90676520] A clinic's engineer/technician reported non-trusty measurement results during diagnostic testing on seven patients. There is no possibility to re-measure correctly. All the required step-by-step troubleshooting was done but the problem still remains and unit is unstable. Upon follow up, it was reported that measurements were not used for the patients surgery. No unexpected end results occurred. No patient harm reported. Seven patients were reported involved. There were no unexpected end results reported. No patient information was available as the doctor did not use results of measurements because they were not trusty. Another piece of equipment was used for diagnostics.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003288808-2017-02254
MDR Report Key6964846
Date Received2017-10-20
Date of Report2018-02-16
Date of Event2017-09-22
Date Mfgr Received2018-02-02
Device Manufacturer Date2009-09-21
Date Added to Maude2017-10-20
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. NADIA BAILEY
Manufacturer StreetAM WOLFSMANTEL 5
Manufacturer CityERLANGEN 91058
Manufacturer CountryGM
Manufacturer Postal91058
Manufacturer Phone8176152330
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 Report0

Device Details

Brand NameALLEGRO OCULYZER
Generic NameDEVICE, ANALYSIS, ANTERIOR SEGMENT
Product CodeMXK
Date Received2017-10-20
Returned To Mfg2018-01-29
Model NumberNA
Catalog Number8065990641
Lot NumberASKU
ID NumberNA
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWAVELIGHT GMBH
Manufacturer AddressAM WOLFSMANTEL 5 ERLANGEN 91058 GM 91058


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-10-20

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