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

Model Number 610-0001

Device Problems Biological Environmental Factor (2887); Device Dislodged or Dislocated (2923)

Patient Problems Corneal Edema (1791); Blurred Vision (2137); Loss of Vision (2139)

Event Date 12/27/2016

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 corneal inlay has not been returned to the manufacturer at this time.Inlay shifts in position, inlay removal, and decreased visual acuity are listed in the device labeling as known adverse events.(b)(4).

Event Description

The raindrop corneal inlay was implanted in the patient's left eye on (b)(6) 2016.At the one-week postoperative visit, meigbomian gland debris was observed under the flap and the inlay was found to have decentered >1 mm inferiorly.On (b)(6) 2017, the inlay was removed, the interface was irrigated and a new raindrop corneal inlay was implanted.The patient's preoperative best corrected distance visual acuity (bcdva) was 20/20 in the operative eye.Postoperatively prior to inlay exchange, the patient's bcdva decreased to 20/50.

Manufacturer Narrative

Age corrected to from (b)(6) to (b)(6) years.Device manufacture date corrected from 09/13/2019 to 09/13/2016.The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection and dimensional analysis.The findings revealed that the inlay had some cuts and tears which is consistent with findings for corneal inlays that have been explanted.The edge thickness and diameter were measured and found to be within specifications.The patient's anatomy is the likely cause of inlay decentration.(b)(4).Reference mdr# 3005956347-2017-00025, for the replacement inlay.

Event Description

An adverse event occurred with the replacement raindrop corneal inlay that was implanted in the patient's left eye on (b)(6) 2017.Reference mdr# 3005956347-2017-00025 which was filed for the replacement inlay for this same patient.

• 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: 6298942
• MDR Text Key: 66427578
• Report Number: 3005956347-2017-00013
• 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
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• 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 Lot Number: 002990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• 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
• Patient Sequence Number: 1
• Treatment: FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR