MAUDE Adverse Event Report: REVISION / RVO 2.0, INC. RAINDROP UNDERLAY LENS; IMPLANT, CORNEAL, REFRACTIVE

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

Patient Problems Blurred Vision (2137); Visual Impairment (2138)

Event Date 10/17/2019

Event Type  Injury  

Event Description

Raindrop lens was surgically inserted in (b)(6) 2017.I now have blurry, hazy vision and poor night vision.Product needs to be surgically removed.Vision after the procedure may be altered negatively due to raindrop lens.Fda safety report id# (b)(4).

• Brand Name: RAINDROP UNDERLAY LENS
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): REVISION / RVO 2.0, INC.
• MDR Report Key: 9218459
• MDR Text Key: 163307150
• Report Number: MW5090519
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 61