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 01/24/2017

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 corneal inlay has not been returned to the manufacturer at this time.Corneal haze and inlay removal are listed in the device labeling as known potential risks.(b)(4).

Event Description

The subject was enrolled in the clinical study for (b)(4) and underwent surgery on (b)(6) 2013 with implantation of the investigational corneal inlay in the left eye.Peripheral edge haze was noted during the study at month 4 and month 12 and was treated with topical steroids.The edge haze was not clinically significant.The patient reported experiencing dissatisfaction with uncorrected near and distance vision over the past six months.Upon examination on (b)(6) 2017, the patient presented with 2+ recurrent corneal haze, although there was no decrease in best corrected distance visual acuity (bcdva) compared to baseline.On (b)(6) 2017, the inlay was explanted due to recurrent corneal haze (and patient's dissatisfaction with uncorrected vision).Additional information has been requested.

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection and dimensional analysis.The findings revealed that the edge of the inlay was wavy because of dehydration which precluded the measurement of edge thickness.The diameter was measured and found to be within specifications.(b)(4).

Event Description

Patient follow-up was requested from the surgeon, who provided the following additional information.Although the patient had recurrent corneal haze, the inlay was primarily explanted due to the patient's dissatisfaction with uncorrected near vision.The patient is stable with a good prognosis.

• 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: 6355387
• MDR Text Key: 68209229
• Report Number: 3005956347-2017-00019
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: G090149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2013
• Device Model Number: PP6-530-0027-US
• Device Lot Number: 002354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR