WAVELIGHT FS200 FEMTOSECOND LASER 8065990941

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 2020-03-31 for WAVELIGHT FS200 FEMTOSECOND LASER 8065990941 manufactured by Wavelight Gmbh.

Event Text Entries

[187086908] 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


[187086909] A director reported a patient had uneventful lasik procedure done. Diffuse lamellar keratitis (dlk) was noted at one day post-operative appointment. A day later, the patient had flap lifted. Approximately one week later, dlk was reported to no longer be present. The patient continues to be monitored. There are two related reports for this patient. This report addresses the patient's left eye and another manufacturer report will be filed for the fellow eye.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003288808-2020-00257
MDR Report Key9904616
Report SourceOTHER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-29
Date Facility Aware2020-03-09
Report Date2020-03-09
Date Reported to Mfgr2020-03-09
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-04-24
Date Added to Maude2020-03-31
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. JONATHAN SCHLECH
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175514979
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 NameWAVELIGHT FS200 FEMTOSECOND LASER
Generic NamePOWERED LASER SURGICAL INSTRUMENT
Product CodeGEX
Date Received2020-03-31
Model NumberNA
Catalog Number8065990941
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age4 YR
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. Required No Informationntervention 2020-03-31

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