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

Model Number 610-0001

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Corneal Edema (1791)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

The inlay remains implanted and is therefore not available for evaluation.The lot number of the inlay was not provided to allow review of the device history record.Inlay shifts in position, corneal edema, and worsening of dry eye symptoms are listed in the device labeling as known potential risks.Complaint reference number: (b)(4).

Event Description

The consumer reported undergoing implantation of the raindrop corneal inlay in the left eye.One day postoperatively, the inlay was noted to be decentered significantly and the inlay was repositioned one week later to address decentration.The consumer also reported experiencing dry eye syndrome.Patient follow-up was requested from the surgeon, who provided the following additional information.The patient underwent uneventful implantation of the corneal inlay on (b)(6) 2017, the inlay was repositioned to address 3-mm inferior decentration of the inlay.There was no significant decrease in the patient's best corrected distance visual acuity (bcdva).The surgeon suspects the lasik flap as the likely cause of the dry eye and corneal edema as a potential contributing factor in the development of the inlay decentration.At last examination on (b)(6) 2017 the patient was stable and improving.

Manufacturer Narrative

The device history record for the manufacturing lot for this device was reviewed and there were no discrepancies or unusual findings related to the reported issue.(b)(4).

• 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: 6801992
• MDR Text Key: 83202524
• Report Number: 3005956347-2017-00091
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• PMA/PMN Number: P150034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/16/2020
• Device Model Number: 610-0001
• 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: 08/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 54 YR