RAINDROP NEAR VISION INLAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for RAINDROP NEAR VISION INLAY manufactured by Revision Optics Incorporated.

Event Text Entries

[128216373] Decreased vision and corneal haze.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081494
MDR Report Key8090457
Date Received2018-11-19
Date of Report2018-11-16
Date of Event2017-03-15
Date Added to Maude2018-11-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRAINDROP NEAR VISION INLAY
Generic NameIMPLANT, CORNEAL, REFRACTIVE
Product CodeLQE
Date Received2018-11-19
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerREVISION OPTICS INCORPORATED
Manufacturer Address25651 ATLANTIC OCEAN DRIVE SUITE A-1 LAKE FOREST CA 92630 US 92630


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-11-19

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