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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Dry Eye(s) (1814); Corneal Clouding/Hazing (1878); Headache (1880); Failure of Implant (1924); Nausea (1970); Blurred Vision (2137); Unspecified Eye / Vision Problem (4471)

Event Date 02/11/2022

Event Type  Injury  

Event Description

Raindrop corneal implant was implanted in 2016 when i was having trouble reading small print.After initial improvement my vision deteriorated past the original state.I went to have the implant removed on (b)(6) 2021.I was told that it would take several months for vision to return to what would be normal.I now have cloudy vision in the left eye and cannot use it to read or much of anything else.I am unable to focus my eyes and get continuous headaches, eye aches, dry eye, and nausea, as well as issues with depth perception.Rvo 2.0 inc., (b)(6).Fda safety report id# (b)(4).

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• MDR Report Key: 14592838
• MDR Text Key: 293378992
• Report Number: MW5110072
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: 2 HEART STENTS ; ASPIRIN ; ATORVASTATIN 80MG TAB ; CLONAZEPAM 1MG TAB AS NEEDED ; CLOPIDOGREL 75MG TAB ; FENOFIBRATE 160MG TAB; FISH OIL ; FLOMAX 0.4MG CAP ; FLUOXETINE 40MG CAP; LISINOPRIL 2.5MG TAB ; MELATONIN ; OXCARBAZEPINE 600MG TAB ; QUETIAPINE FUMARAT 50MG TAB ; VITAMIN D2 (ERGO)50,000IU CAP
• Patient Outcome(s): Other; Disability
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White