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

Lot Number 003071

Patient Problems Corneal Clouding/Hazing (1878); Failure of Implant (1924); Blurred Vision (2137)

Event Date 02/09/2023

Event Type  Injury  

Event Description

In 2017 i had the raindrop eye implant put in.It worked fine in the beginning and then around 2020 i had to use reading glasses again, the vision in my left eye (that has the raindrop implanted) got blurry in 2021/2022.I researched online about the raindrop and noticed it had a recall, i never was notified of a recall.I called the doctor that implanted the raindrop and had an appointment in (b)(6) 2023 he stated there was hazing on the eye and started me on eye drops to see if the haze would go away, i had a follow up with him in (b)(6) 2023, (b)(6) 2023, and just last week where his recommendation was to remove the implant.He stated my vision would be worse when they remove the raindrop since my eye will be flatter.I will have the raindrop removed on (b)(6) 2023.

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): REVISION OPTICS
• MDR Report Key: 17799390
• MDR Text Key: 324146673
• Report Number: MW5146043
• 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: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 003071
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White