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

Model Number 610-0001

Device Problems Biological Environmental Factor (2887); Device Contamination with Chemical or Other Material (2944)

Patient Problems Loss of Vision (2139); No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

The device was discarded by the facility and is not available for evaluation.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.Inlay exchange is listed in the device labeling as a potential risk.(b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay in the right eye.At the one day postoperative visit, debris (fiber) was observed on the inlay at the 4 o'clock position.The inlay was replaced with a new inlay.There is no known adverse impact to the vision.The source of the debris is not known at this time.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

Patient follow-up was requested from the surgeon, who provided the following additional information.The patient's best corrected distance visual acuity decreased from 20/20 (preoperatively) to 20/60 (prior to replacement of the initial inlay).Post implantation of the replacement inlay, the patient's bcdva improved to 20/30.The source of the debris was identified as the surgical environment.

Manufacturer Narrative

Corrected information: age or date of birth.Additional information: ethnicity, event or problem.Complaint reference number: (b)(4).

Event Description

The surgeon reports that at the 6 month follow-up visit on (b)(6) 2017, the corneal flap was smooth and the inlay was clear and in position.There were no abnormal findings from the slit lamp exam and the patient will receive routine 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: 6341741
• MDR Text Key: 67810284
• Report Number: 3005956347-2017-00017
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 58 YR