MAUDE Adverse Event Report: REVISION OPTICS / RVO 2.0, INC. RAINDROP CORNEAL INLAY; IMPLANT, CORNEAL, REFRACTIVE - RAINDROP POOR VISION INLAY

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Corneal Clouding/Hazing (1878); Headache (1880); Blurred Vision (2137); No Code Available (3191)

Event Date 03/22/2019

Event Type  Injury  

Event Description

Fin (b)(6) 2017, i had a raindrop corneal inlay implanted in my right eye.One year later in (b)(6) 2018, i developed corneal haze which affected my vision.I had the lens replaced and the haze was treated.Approx 1 yr later in (b)(6) 2019, i developed the haze again and this time caused headaches.Blurred vision, and loss of depth perception.On (b)(6) , i had the inlay removed.Fda safety report id# (b)(4).

• Brand Name: RAINDROP CORNEAL INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE - RAINDROP POOR VISION INLAY
• Manufacturer (Section D): REVISION OPTICS / RVO 2.0, INC.
• MDR Report Key: 8487179
• MDR Text Key: 141105299
• Report Number: MW5085602
• 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: 04/02/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 81MG ASPIRIN ; APPLE CIDER VINEGAR; ATORVASTATIN; CARVIDIOL; CINNAMON CAPSULES; LEVOTHYROXINE; LISINOPRIL; METFORMIN ; VITAMIN D3
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 100