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 foreign,health professional report with the FDA on 2020-03-17 for LENSX LASER SYSTEM 550 8065998162 manufactured by Alcon Lensx, Inc..

Event Text Entries

[183756273] 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


[183756274] A customer reported a patient with inflammation and mild haze in both eyes post laser treatment. The topical steroid dosage was increased. Additional information received states the eye is clear. 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 Number2028159-2020-00241
MDR Report Key9842453
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2020-02-19
Date Mfgr Received2020-02-24
Device Manufacturer Date2018-01-30
Date Added to Maude2020-03-17
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 G1ALCON LENSX, INC.
Manufacturer Street33 JOURNEY SUITE #175
Manufacturer CityALISO VIEJO CA 92658
Manufacturer CountryUS
Manufacturer Postal Code92658
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 Received2020-03-17
Model Number550
Catalog Number8065998162
Lot NumberASKU
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. Required No Informationntervention 2020-03-17

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