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

Model Number 610-0001

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problems Corneal Clouding/Hazing (1878); Inflammation (1932); Keratitis (1944); Blurred Vision (2137); Visual Impairment (2138); Loss of Vision (2139)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

The explanted device is expected to be returned to the manufacturer.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.Inlay decentration is listed in the device labeling as a known complication of corneal inlay surgery.Dlk is also listed in the device labeling and is commonly associated with corneal flap procedures.The off-label use of celluvisc may have been contributory.Complaint reference number: (b)(4).Date emdr submitted to fda: 12/21/2016.

Event Description

Corneal inlay implantation was performed on (b)(6) 2016 on the left eye.At the one-day postoperative visit, the patient presented with blurred vision and inflammation in the operative eye and diffuse lamellar keratitis (dlk), grade 2, was diagnosed.Steroid administration was increased to hourly.The patient's preoperative best corrected distance visual acuity (bcdva) was 20/20.During investigation of the reported issue, it was discovered that at the end of the procedure several drops of celluvisc had been instilled on the corneal flap.New information was received on november 23, 2015 indicating that the inlay will be explanted.Additional information was requested and on december 15, 2016 the surgeon provided the following update.Initially, the patient's postoperative bcdva decreased from 20/20 to 20/100, but improved to 20/40 on (b)(6) 2016.Prior to inlay explantation the inlay was clear and dlk had decreased to grade 1, but the inlay had decentered nasally.On (b)(6) 2016, the flap was lifted and irrigated and the inlay was removed and replaced with a new inlay in order to address decentering (and dlk).

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection.The findings revealed that the inlay was folded and dehydrated.As a result no dimensional measurements could be performed.Complaint reference# (b)(4).Date esmdr submitted: 03/02/2017.

Event Description

Two weeks post inlay exchange, the patient's best corrected distance visual acuity (bcdva) remained unchanged at 20/40.On (b)(6) 2017, bcdva improved to 20/30.There is residual mild corneal haze observed just outside the area of inlay.Steroid treatment is being tapered.

Manufacturer Narrative

Correction for 3005956347-2016-00011-001: [correct information for received by mfr date is 02/01/2017 and not 01/27/2017].(b)(4).

Event Description

Patient's current status was requested and the following update was provided on august 1, 2017: the patient was last examined on (b)(6) 2017, the patient's best corrected visual acuity (bcdva) was 20/40 and the patient was directed to continue artificial tears.

• 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: 6194508
• MDR Text Key: 62982029
• Report Number: 3005956347-2016-00011
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)190808(10)002979
• 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,Followup,Followup
• Report Date: 08/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002979
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; 08/01/2017
• Supplement Dates FDA Received: 03/02/2017; 08/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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: CELLUVISC ARTIFICIAL TEARS; FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR