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

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

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Raindrop near vision inlay was implanted and caused irreparable damage to cornea and vision.Fda safety report id# (b)(4).

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): REVISION OPTICS, INC. /RVO 2.0, INC.
• MDR Report Key: 8964884
• MDR Text Key: 156765225
• Report Number: MW5089551
• 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: 08/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 57