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

Model Number 610-0001

Device Problems Contamination (1120); Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

The device history record 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 has not been received at this time.Please reference the attached medication alert for durezol.Complaint reference number: (b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay in the left eye.During surgery, durezol was instilled and then the corneal flap was re-lifted several times in an attempt to optimize flap positioning.During the same day examinations (day 0), debris was observed in the interface.The patient was monitored throughout the early postoperative period and there was no progression, but no improvement.The interface debris was suspected to be residual durezol.The inlay was explanted six days postoperatively and the interface was irrigated copiously with balanced salt solution.Additional information is being requested.

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection analysis.Several dark and light, in color, particulates were observed on the device.Since these findings are consistent with the findings for corneal inlays that have been explanted, it could not be determined if the particulates were remains of durezol as suspected in the reported complaint information.The particulates observed are similar to what is expected for the handling of explanted inlays.Complaint reference number: (b)(4).

• 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: 6251962
• MDR Text Key: 64889834
• Report Number: 3005956347-2017-00006
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)190913(10)002990
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3005956347-02/03/17-001
• Patient Sequence Number: 1
• Treatment: DUREZOL; FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR