MAUDE Adverse Event Report: REVISION OPTICS/RVO 2.0 INC. RAINDROP INLAY; IMPLANT, CORNEAL, REFRATIVE

Device Problem Nonstandard Device (1420)

Patient Problems Dry Eye(s) (1814); Pain (1994); Blurred Vision (2137); Visual Impairment (2138)

Event Date 11/10/2017

Event Type  Injury  

Event Description

I had the raindrop inlay put in my eye.Not only did it not work after more than a year of waiting for my eyes to adjust¿ to it, it got recalled.Since it was removed, my vision is impaired in the affected eye.Even with glasses, i have blurry distance vision.And i have a very dry eye that is painful at times.Fda safety report id # (b)(4).

• Brand Name: RAINDROP INLAY
• Type of Device: IMPLANT, CORNEAL, REFRATIVE
• Manufacturer (Section D): REVISION OPTICS/RVO 2.0 INC.
• MDR Report Key: 9621955
• MDR Text Key: 176228631
• Report Number: MW5092424
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 66