RAINDROP 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 INLAY manufactured by Revision Optics Incorporated.

Event Text Entries

[128180546] Corneal haze, decreased vision.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081486
MDR Report Key8090034
Date Received2018-11-19
Date of Report2018-11-16
Date of Event2017-08-09
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 INLAY
Generic NameIMPLANT, CORNEAL, REFRACTIVE
Product CodeLQE
Date Received2018-11-19
Lot Number003109
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerREVISION OPTICS INCORPORATED


Patients

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

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