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

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

Patient Problem Blurred Vision (2137)

Event Date 09/07/2017

Event Type  Injury  

Event Description

I had the raindrop near vision inlay procedure.Immediately after the procedure and ever since, i have reported to my eye dr that the inlay did not work, did not help with my near vision and caused blurriness and glare.I was told it takes a long time for this to go away.It has never gone away and my vision is worse with the inlay than before i had the procedure done.

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): REVISION OPTICS, INC.; 25651 atlantic ocean dr; ste a-1; lake forest CA 92630
• MDR Report Key: 8110851
• MDR Text Key: 128746914
• Report Number: MW5081663
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 61