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

Lot Number 003054

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

Patient Problems Corneal Clouding/Hazing (1878); Visual Impairment (2138)

Event Date 07/26/2017

Event Type  Injury  

Event Description

Decreased vision and corneal edema.

• Brand Name: RAINDROP INLAY
• Type of Device: IMPLANT CORNEAL REFRACTIVE
• Manufacturer (Section D): REVISION OPTICS INC.
• MDR Report Key: 8090039
• MDR Text Key: 128180588
• Report Number: MW5081490
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 003054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR