MAUDE Adverse Event Report: RVO 2.0, INC RAIN DROP NEAR VISION INLAY; IMPLANT, CORNEAL, REFRACTIVE

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

Patient Problems Itching Sensation (1943); Swelling (2091); Blurred Vision (2137)

Event Type  malfunction  

Event Description

I don't know the exact date, my eyes really started itching in early summer, i thought maybe allergies so i waited it out.My eyes are even worse now, itch all the time, water and tear and are blurry.I continue to get eye sty's and tender eyelids along with swelling in the corner of my eye.I have an appt with my eye dr on monday, (b)(6) 2019.Optics medical.

• Brand Name: RAIN DROP NEAR VISION INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): RVO 2.0, INC
• MDR Report Key: 9505961
• MDR Text Key: 172565919
• Report Number: MW5091821
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 70