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

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

Patient Problems Failure of Implant (1924); Blurred Vision (2137)

Event Date 07/15/2018

Event Type  Injury  

Event Description

After approximately 1 1/2 years of raindrop inlay, blurry vision, halos, asked for a correction but nothing available.Approximately 2021 had inlay removed.Permanent haze and blurry vision.

• Brand Name: RAINDROP INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• MDR Report Key: 16158209
• MDR Text Key: 307497148
• Report Number: MW5114327
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic
• Patient Race: White