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

Model Number 610-0001

Device Problem Wrinkled (2614)

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

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

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.The inlay became lost during the secondary surgical intervention and is not available for evaluation.Lifting of the corneal flap to treat inlay-related complications is listed in the device labeling as a known potential risk.Complaint reference number: (b)(4).Date emdr submitted to fda: 03/16/2017.

Event Description

The patient underwent implantation of the corneal inlay in the left eye on (b)(6) 2017.Corneal striae was observed at the postoperative slit lamp examination.On (b)(6) 2017, the surgeon smoothed the corneal surface, but visual acuity did not improve.On (b)(6) 2017, the corneal flap was lifted in order to attempt to address a wrinkled inlay, however, during lifting of the flap the inlay became lost.Additional attempts were made to implant a new inlay, but these were not successful and no replacement inlay was implanted.At this time, there is no information on the impact to best corrected distance visual acuity (bcdva) as a result of the wrinkled inlay.Additional information has been requested.

Manufacturer Narrative

Complaint reference #: (b)(4).

Event Description

The surgeon provided the following new information.Preoperatively, the patient's best corrected distance visual acuity (bcdva) was 20/20, however bcdva was not measured prior to explant.At last examination 6 weeks post inlay removal, the patient's bcdva was 20/60; the patient is healing and has not yet returned for follow-up.The surgeon believes the wrinkled inlay was caused by corneal striae and stromal bed abnormalities.

• 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: 6411251
• MDR Text Key: 70181918
• Report Number: 3005956347-2017-00027
• 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
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2017
• 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: 54 YR