MAUDE Adverse Event Report: REVISION OPTICS, INCORPORATED RAINDROP INLAY; IMPLANT, CORNEAL, REFRACTIVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Clouding/Hazing (1878); Failure of Implant (1924)

Event Type  Injury  

Event Description

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.

• Brand Name: RAINDROP INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): REVISION OPTICS, INCORPORATED
• MDR Report Key: 8089417
• MDR Text Key: 128180578
• Report Number: MW5081455
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR