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

Model Number PP6-530-0027-US

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

Patient Problems Corneal Clouding/Hazing (1878); Visual Disturbances (2140)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

The explanted corneal inlay has not been returned to the manufacturer at this time.The site is being contacted to determine whether it is still available for analysis.The device history record review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.Increased visual symptoms, corneal haze, and interface debris are listed in the device labeling as known potential risks.(b)(4).

Event Description

The subject was enrolled in a foreign clinical trial and underwent uneventful implantation of the investigational corneal inlay in the left eye on (b)(6) 2016.The study involved the use of mitomycin-c and lasik surgery was performed concurrent with inlay implantation.On (b)(6) 2017, the inlay was explanted in order to address unspecified visual disturbances.Additional information was requested from the investigator who reports that the patient also had corneal haze and interface debris.The patient's visual disturbances were described as mild halos and moderate double vision with onset at month 15, but the symptoms did not significantly impair the patient's activities of daily living.The type and grade of corneal haze was not provided and the relationship between haze and the visual symptoms is not known.The visual disturbances were thought to be caused by extended debris in the flap interface.

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; lake forest CA 92630 8835
• Manufacturer (Section G): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; lake forest CA 92630 8835
• Manufacturer Contact: pushpita singh ; 25651 atlantic ocean dr.,; ste. a1; lake forest, CA 92630-8835 ; 9497072740
• MDR Report Key: 7134875
• MDR Text Key: 95384242
• Report Number: 3005956347-2017-00161
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P150034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/01/2017
• Device Model Number: PP6-530-0027-US
• Device Lot Number: 002627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXCIMER LASER FOR LASIK; FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR