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 Problems Dry Eye(s) (1814); Pain (1994); Loss of Vision (2139)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was not available for evaluation.The device history record (dhr) review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Epithelial ingrowth, decreased vision, and visual symptoms are listed in the device labeling as a known potential risks.(b)(4).

Event Description

The patient underwent uneventful implantation of the raindrop corneal inlay in the right eye on (b)(6) 2017.One week postoperatively the patient presented with rapid epithelial ingrowth (grade ii), which required a flap lift and scrape and the inlay was exchanged with another inlay on (b)(6) 2017.The ingrowth was associated with intolerable visual disturbances (photophobia), and the best corrected distance visual acuity (bcdva) decreased more than 2 lines.The patient is doing well post inlay exchange, but dryness persists.

Manufacturer Narrative

(b)(4).

Event Description

The surgeon reports that post inlay exchange the patient is doing great with bcdva 20/20.

Manufacturer Narrative

(b)(4).

Event Description

The surgeon provided the following additional information.The most recent patient's best corrected distance visual acuity (bcdva) is 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: 6661069
• MDR Text Key: 78181261
• Report Number: 3005956347-2017-00058
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/16/2020
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR