FEMTO FEMTO Z4 PP 510.003.004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-16 for FEMTO FEMTO Z4 PP 510.003.004 manufactured by Sie Ag, Surgical Instrument Engineering.

Event Text Entries

[187258921] Pt underwent lasik ou (b)(6) 2019. Developed dlk od, steroid pf increased to qhr od. Flap lift (b)(6) 2019 od. (b)(6) 2019 po vasc 20/40 od, 20/20 os. Rxm od no improvement. Will continue to monitor as epi remodels. Ar approx +2. 50 at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005643720-2020-00001
MDR Report Key9595312
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-01-16
Date of Report2020-01-15
Date of Event2019-11-23
Date Mfgr Received2019-12-17
Device Manufacturer Date2018-04-30
Date Added to Maude2020-01-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPHD MICHELA PEISINO
Manufacturer StreetALLMENDSTRASSE 11
Manufacturer CityPORT, BE CH-2562
Manufacturer CountrySZ
Manufacturer PostalCH-2562
Manufacturer G1SIE AG, SURGICAL INSTRUMENT ENGINEERING
Manufacturer StreetALLMENDSTRASSE 11
Manufacturer CityPORT, CH-2562
Manufacturer CountrySZ
Manufacturer Postal CodeCH-2562
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFEMTO
Generic NameFEMTO LDV Z4
Product CodeHQF
Date Received2020-01-16
Model NumberFEMTO Z4 PP
Catalog Number510.003.004
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIE AG, SURGICAL INSTRUMENT ENGINEERING
Manufacturer AddressALLMENDSTRASSE 11 PORT, CH-2562 SZ CH-2562


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-16

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