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

Model Number 610-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Abrasion (1789); Corneal Ulcer (1796); Inflammation (1932); Visual Impairment (2138)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was discarded by the facility and is not available for evaluation.The device history record (dhr) review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.Epithelial defect, recurrent corneal erosion, decreased bcdva, and inlay removal are listed in the device labeling as known potential risks.(b)(4).

Event Description

The patient underwent uneventful implantation of the raindrop corneal inlay in the right eye on (b)(6) 2016.Postoperatively the patient developed a persistent non-healing epithelial defect in the operative eye, which was initially located at the superior flap edge and later involved the entire flap surface, approximately 5 mm round.At first onset 2 weeks postoperatively, the patient reported experiencing eye redness, photophobia, and blurred vision with periods of exacerbation and improvement.One month postoperatively the patient was diagnosed with epithelial basement membrane dystrophy (ebmd) in both eyes and the patient disclosed possible eye rubbing.On (b)(6) 2017, the patient presented with recurrent corneal erosion and bcdva decreased to 20/400; the inlay was subsequently explanted on (b)(6) 2017.On april 6, 2017, the patient presented with a neurotropic corneal ulcer and central corneal haze (grade 1-2+); the cornea was cultured and the culture report showed no bacterial or fungal growth.According to the surgeon, the corneal haze was not related to the corneal inlay with onset occurring only after inlay removal.At last examination on (b)(6) 2017, the patient was not improving and the prognosis is guarded.The epithelium has not healed, vision remains 20/400 - hand motion, and a corneal transplant is likely needed.In the surgeon's opinion, the likely causes/contributing factors include subclinical ebmd and the gutter surrounding the corneal flap did not re-epithelialize in an expected manner.

Manufacturer Narrative

(b)(4).

Event Description

Patient follow-up was requested and the following information was received on (b)(6) 2017.The patient received a therapeutic corneal transplant on (b)(6) 2017.The patient is doing well post transplantation.

Manufacturer Narrative

(b)(4).

Event Description

Patient follow-up was requested and the following update was received.The patient was examined on (b)(6) 2017 at which time vision had decreased to hand motion with a diagnosis of an acute corneal melt.The patient was referred to a corneal specialist for consideration of emergent penetrating keratoplasty.The most recent update revealed that the corneal melt was able to be controlled with bcdva improving to 20/100 and the eye is quiet with persistent corneal haze.Corneal culture was completed with no growth, but the patient developed 50% hypopyon; cultures were completed again with no growth.A transplant will be considered once the inflammation completely resolves.

Manufacturer Narrative

(b)(4).

Event Description

The following update was received on october 30, 2017: the corneal transplantation was successful, and the patient experienced a full re-epithelialization of the graft.

• 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: 6575636
• MDR Text Key: 75453999
• Report Number: 3005956347-2017-00043
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/22/2019
• Device Model Number: 610-001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• 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
• Patient Sequence Number: 1
• Treatment: FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP
• Patient Outcome(s): Disability
• Patient Age: 56 YR