IDESIGN AWS SYSTEM 0110-3450

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 2020-03-12 for IDESIGN AWS SYSTEM 0110-3450 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[183162118] The device manufacture date was not available at the time of this report. ((b)(4). The system was evaluated by a field service engineer. The field service found no issues with the unit. A field service checklist was performed. The unit complied with all factory settings. A review of records related to the device including labeling, complaint trending, and risk documentation will be performed. Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[183162119] It was reported that a laser vision correction patient had surgery on (b)(6) 2020 which resulted in 2 diopters of induced astigmatism in the right eye. The patient was iol implant. The case was photorefractive keratectomy (prk) utilizing amoils brush to remove epithelium. Pre op manifest: -2. 50 +4. 25 x 100. This report is for the idesign. A separate report will be filed for the excimer laser.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006695864-2020-00175
MDR Report Key9824738
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-01-30
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-12
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 ContactSOMYATA NAGPAL
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478200
Manufacturer G1JOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Street510 COTTONWOOD DRIVE
Manufacturer CityMILPITAS CA 95035
Manufacturer CountryUS
Manufacturer Postal Code95035
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameIDESIGN AWS SYSTEM
Generic NameREFRACTIVE MEASUREMENT
Product CodeHKO
Date Received2020-03-12
Model Number0110-3450
Catalog Number0110-3450
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Address1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

Product Code---
Date Received2020-03-12
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-12

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