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

Model Number 610-0001

Device Problem Malposition of Device (2616)

Patient Problem Loss of Vision (2139)

Event Date 01/25/2017

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 explanted inlay was discarded by the facility and is not available for evaluation.Inlay shifts in position, repositioning and inlay removal are listed in the device labeling as known potential risks.(b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay in the right eye on (b)(6) 2016.The corneal inlay was repositioned on (b)(6) 2017 in order to address superior placement of the inlay (decentered inlay) approximately 4 mm due the microscope being offset.The patient's initial best corrected distance visual acuity (bcdva) prior to inlay repositioning was 20/20 (no change from preoperative bcdva).The surgeon reports that the patient was impatient with the healing process and the inlay was later explanted to address inlay decentration, bcdva decrease to 20/40, and patient dissatisfaction.The patient was last examined on (b)(6) 2017 at which time bcdva improved to 20/20.

• 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: 6528571
• MDR Text Key: 74090845
• Report Number: 3005956347-2017-00037
• 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
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: 610-0001
• Device Lot Number: 002968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• 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
• Patient Age: 51 YR