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

Model Number 610-0001

Device Problems Wrinkled (2614); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2017

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) for this manufacturing lot was reviewed and the device met all release criteria and there were no discrepancies or unusual findings that relate to the reported event.The explanted inlay was lost at the healthcare facility and is not available for evaluation.Secondary surgical intervention to remove or exchange the inlay is listed in the device labeling as a known potential risk.(b)(4).Date emdr submitted to fda: 04/07/2017.

Event Description

The patient underwent implantation of the raindrop corneal inlay on (b)(6) 2017.Striae (wrinkles on the inlay and/or corneal flap) was observed one-day postoperatively.The inlay was removed on (b)(6) 2017 and a new inlay was implanted on (b)(6) 2017.Additional information has been requested.

Manufacturer Narrative

There is no product problem (malfunction).Type of reportable event is not a serious injury.(b)(4).

Event Description

New information was received on april 20, 2017.The new information clarified that the striae was located on the corneal flap and there were no wrinkles observed on the inlay.Therefore, the device did not contribute to the secondary surgical intervention.

• 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: 6473702
• MDR Text Key: 72173057
• Report Number: 3005956347-2017-00033
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)191108(10)003027
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2019
• Device Model Number: 610-0001
• Device Lot Number: 003027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• 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: FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP