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

Model Number 610-0001

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Corneal Edema (1791); Loss of Vision (2139)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

The device history record for the 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 swelling, inlay shifts in position, inlay removal, and decreased visual acuity are listed in the device labeling as potential risks.(b)(4).Date emdr submitted to fda: 03/03/2017.Reference mdr# 3005956347-2017-00013 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) 2017.Reference mdr# 3005956347-2017-00013, which was filed for an adverse event involving the first inlay implanted in this patient.Additional information was received and it was learned that one day following inlay exchange, there was significant corneal flap edema and bcdva had worsened to 20/80.On (b)(6) 2017, the replacement inlay was fully decentered and the patient's bcdva was 20/40.The inlay was explanted on (b)(6) 2017.One week post explantation, bcdva improved to 20/30+.On (b)(6) 2017, the patient's bcdva returned to baseline.The inlay decentration was thought to be caused by patient's anatomy.

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection and dimensional analysis.The findings revealed that the inlay was damaged with a tear and some scratches and abrasions were observed on the inlay.The damaged condition of the device is consistent with the findings for corneal inlays that have been explanted.The edge thickness and diameter were measured and found to be within specifications.(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: 6378961
• MDR Text Key: 69094213
• Report Number: 3005956347-2017-00025
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)190916(10)002999
• 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
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2019
• Device Model Number: 610-0001
• Device Lot Number: 002999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR