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 Problem Corneal Clouding/Hazing (1878)

Event Date 04/26/2017

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was discarded by the facility and is not available for evaluation.The device history record (dhr) review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.Corneal haze is listed in the device labeling as a known potential risk.(b)(4).

Event Description

The subject was enrolled in a foreign clinical trial and underwent implantation of the investigational corneal inlay in the left eye on (b)(6) 2016.The patient was examined postoperatively at a clinic in the u.S.At this visit corneal haze was observed surrounding the inlay, which was explanted on (b)(6) 2017.Additional information has been requested.

• 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: 6786975
• MDR Text Key: 82457959
• Report Number: 3005956347-2017-00086
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/10/2017

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: 06/01/2017
• Device Model Number: PP6-530-0027-US
• Device Lot Number: 002593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR