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 Clouding/Hazing (1878); Keratitis (1944); Blurred Vision (2137); Loss of Vision (2139)

Event Date 11/16/2016

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 inlay was discarded by the facility and is not available for evaluation.Inlay shifts in position, inlay removal, dlk, and decreased visual acuity are listed in the device labeling as known complications.This mdr is being filed for the first inlay that was implanted on (b)(6) 2016.Please reference mdr # 3005956347-2017-00010 for the second inlay that was implanted on (b)(6) 2016.(b)(4).

Event Description

The raindrop corneal inlay was implanted in the patient's left eye on (b)(6) 2016.The initial information suggested that four days postoperatively there was debris under the flap and the flap was lifted and irrigated, the inlay was removed, and a new raindrop inlay was implanted.At this time the patient's vision was reported as great and the corneal inlay was not suspected as contributory.Clinical follow-up information was requested from the surgeon and on (b)(6) 2016, the following additional information was provided.Although there were no intraoperative complications, the inlay decentered one-day postoperatively and the slit lamp examination showed debris under the flap and mild dlk (diffuse lamellar keratitis).The flap debris was located everywhere under the flap and not specifically localized to the inlay.At the 4-day postoperative visit, the flap was lifted and the inlay was removed and replaced with a new inlay.The week of (b)(6) 2016, the inlay was significantly decentered again and the inlay was explanted and the flap was irrigated to remove debris from underneath the flap.The patient's preoperative best corrected distance visual acuity (bcdva) was 20/20 in the operative eye.Postoperatively, the patient's bcdva decreased to 20/40.The surgeon suspects that a rough flap bed caused the development of the flap debris, but the inability to irrigate under the flap after replacing the inlay was contributory.The surgeon anticipates a full visual recovery.

Manufacturer Narrative

Correction: replacement inlay was not explanted and remains implanted.(b)(4) (initial inlay).Reference mdr# 3005956347-2017-00010 for the replacement inlay (b)(4).

Event Description

Patient follow-up was requested from the surgeon, who provided the following additional information.It was clarified that the replacement inlay was not explanted.The patient was last examined on (b)(6) 2017.During this exam, the replacement inlay was well positioned.Trace peripheral interface haze and debris were observed, with few focal spots of epithelial ingrowth.The patient's best corrected distance visual acuity (bcdva) was 20/40 (pinhole).After this visit, the patient missed her scheduled appointments.The patient is presumed to have lost for follow-up.

• 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: 6258996
• MDR Text Key: 65024913
• Report Number: 3005956347-2017-00008
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)190801(10)002968
• 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
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

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: 08/01/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2016
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: 08/04/2017
• Supplement Dates FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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: 55 YR