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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Eye Injury (1845); Corneal Clouding/Hazing (1878); Eye Infections (4466)

Event Date 02/12/2019

Event Type  Injury  

Event Description

I had raindrop implants in (b)(6) and developed eye infections and hazy vision but moved to (b)(6) since.Doctor said the permanent damage caused by raindrop prevents me from ever wearing contacts.My vision cannot be corrected.It is permanently damaged.Fda safety report id #: (b)(4).

• Brand Name: RAINDROP EYE IMPLANT
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): RVO 2.0, INC
• MDR Report Key: 11893070
• MDR Text Key: 253138988
• Report Number: MW5101561
• Device Sequence Number: 2
• Product Code: LQE
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 05/24/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 56 YR