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

Model Number 610-0001

Device Problems Use of Device Problem (1670); Biological Environmental Factor (2887)

Patient Problems Dry Eye(s) (1814); Pain (1994)

Event Date 10/07/2016

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.(b)(4).

Event Description

The raindrop corneal inlay was implanted in the patient's left eye on (b)(6) 2016.The slit lamp examination after implantation, showed debris on the inlay which was suspected to be meibomian gland secretion.The patient complained of hazy vision, soreness and dry eye.The inlay was removed on (b)(6) 2016 and a new raindrop inlay was implanted.Additional information is being requested.

• 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: 6259019
• MDR Text Key: 65026612
• Report Number: 3005956347-2017-00009
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• 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?: Yes
• Date Manufacturer Received: 12/05/2016
• 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 Age: 48 YR