LENSX LASER SYSTEM 550 8065998162

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-05 for LENSX LASER SYSTEM 550 8065998162 manufactured by Alcon Lensx, Inc..

Event Text Entries

[177940233] 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


[177940234] An eyecare professional reported black holes during flap creation. Parts of the interface of the flap were not lasered. Error was not recognizable on the machine. Procedure was completed. Extended healing process was caused by massive manipulation to lift the flap. New information was received. No error message was recognizable on the machine. There are multiple related reports for this facility. This report addresses the patient on (b)(6) 2019 left eye and other manufacturer reports will be filed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2020-00067
MDR Report Key9674540
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-05
Date of Report2020-02-05
Date of Event2019-12-06
Date Mfgr Received2020-01-13
Device Manufacturer Date2014-03-31
Date Added to Maude2020-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JASON MICHAELIDES
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175686438
Manufacturer G1ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
Manufacturer Street15800 ALTON PARKWAY SUITE #175
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameLENSX LASER SYSTEM
Generic NameOPHTHALMIC FEMTOSECOND LASER
Product CodeOOE
Date Received2020-02-05
Model Number550
Catalog Number8065998162
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON LENSX, INC.
Manufacturer Address33 JOURNEY SUITE #175 ALISO VIEJO CA 92658 US 92658


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-05

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