MAUDE Adverse Event Report: RVO 2.0, INC. RAINDROP; IMPLANT, CORNEAL, REFRACTIVE

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

Patient Problems Inflammation (1932); Blurred Vision (2137); Clouding, Central Corneal (2228)

Event Date 07/12/2019

Event Type  Injury  

Event Description

My vision was getting progressively worse with blurred vision, focusing issues and having to wear readers more often.Could not drive at night due to starry vision.Eye exam indicated in inflammation and cloudy cornea.Diagnosis or reason for use: improve vision.

• Brand Name: RAINDROP
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): RVO 2.0, INC.
• MDR Report Key: 8874255
• MDR Text Key: 153864421
• Report Number: MW5088888
• Device Sequence Number: 0
• Product Code: LQE
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 61