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

Model Number 610-0001

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

Patient Problem Loss of Vision (2139)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer; however, microscopic visual inspection revealed there was no inlay inside the contact lens case and no further analysis could be performed.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Decreased visual acuity is listed in the device labeling as a known potential risk.Please reference mfr report # 3005956347-2017-00015 for the initial inlay ((b)(4)).

Event Description

The patient underwent uneventful implantation of the raindrop corneal inlay in the right eye on (b)(6) 2017.The inlay was explanted on (b)(6) 2017 in order to address decreased best corrected distance visual acuity (bcdva) from 20/20 (preoperatively) to 20/50+.Post explant, bcdva improved to 20/40 and vision is expected to improve further with time.

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; 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: 6916071
• MDR Text Key: 88236417
• Report Number: 3005956347-2017-00115
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013
• 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
• Type of Report: Initial
• Report Date: 10/04/2017

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: Physician
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/05/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR