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

[128180578] I had a raindrop inlay implanted in (b)(6) 2017. I almost immediately had problems with haziness in that eye and it has progressively gotten worse. I was just told to see my ophthalmologist and he suggested steroids, but i am very upset and confused. I wish the fda and my doctor had told patients that this was just experimental still and/or that i had had access to better advice from the start. Very, very unhappy about this inlay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081455
MDR Report Key8089417
Date Received2018-11-19
Date of Report2018-11-15
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 OccupationPATIENT
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
Device AvailabilityY
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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