AIR OPTIX NIGHT & DAY AQUA CBV92002040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-01 for AIR OPTIX NIGHT & DAY AQUA CBV92002040 manufactured by Pt. Ciba Vision Batam.

MAUDE Entry Details

Report Number9681121-2020-00001
MDR Report Key9537126
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-01
Date of Report2020-01-31
Date of Event2019-12-01
Date Mfgr Received2020-01-09
Device Manufacturer Date2019-02-27
Date Added to Maude2020-01-01
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 G1PT. CIBA VISION BATAM
Manufacturer StreetBERINGIN KAV. #204 BATAMINDO INDUSTRIAL PARK MUKA KUNING
Manufacturer CityPULAU BATAM 29433
Manufacturer CountryID
Manufacturer Postal Code29433
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameAIR OPTIX NIGHT & DAY AQUA
Generic NameLENSES, SOFT CONTACT, DAILY WEAR
Product CodeLPL
Date Received2020-01-01
Model NumberNA
Catalog NumberCBV92002040
Lot Number31392997
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPT. CIBA VISION BATAM
Manufacturer AddressBERINGIN KAV. #204 BATAMINDO INDUSTRIAL PARK MUKA KUNING PULAU BATAM 29433 ID 29433


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-01

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