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 Problems Irritation (1941); Loss of Vision (2139)

Event Date 01/27/2017

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 was discarded by the facility and is not available for evaluation.Epithelial defects, inflammation, inlay removal, and decreased visual acuity are listed in the device labeling as known adverse events.Please reference the attached medication alert for durezol.(b)(4).Date emdr submitted to fda: 03/02/2017.Reference mdr # 3005956347-2017-00007 for the event involving the initial inlay.

Event Description

A replacement raindrop corneal inlay was implanted in the patient's left eye on (b)(6) 2016.Reference mdr# 3005956347-2017-00007, which was filed for an adverse event involving the first inlay implanted in this patient.Additional information was received and it was learned that excessive patient movement during the initial surgery on (b)(6) 2016 resulted in an epithelial defect.On (b)(6) 2017, debris from durezol was observed in the interface and the patient's bcdva decreased to 20/40 and there was ocular irritation, but it was improving.The replacement inlay was explanted and the interface was copiously irrigated with balanced salt solution.One week after the inlay was explanted the interface was clearing and uncorrected distance vision improved to 20/25-2 (baseline was 20/20).

• 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: 6375176
• MDR Text Key: 68965334
• Report Number: 3005956347-2017-00021
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)190822(10)002984
• 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
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2019
• Device Model Number: 610-0001
• Device Lot Number: 002984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2016
• 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: 58 YR