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 No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

The inlay remains implanted in the patient and is not available for evaluation.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Inlay shifts in position is listed in the device labeling as a known potential risk.Reference mfr report # 3005956347-2017-00117 for the initial inlay serial# 002979-337; and mfr report #3005956347-2017-00118 for the replacement inlay serial # (b)(4).

Event Description

A replacement raindrop corneal inlay was implanted in the patient's left eye on (b)(6) 2017; the procedure was uneventful and proper inlay centration was verified.At some point during the first postoperative week, the inlay decentered 0.75 mm inferiorly.On (b)(6) 2017, bcdva was 20/25, which was a significant improvement compared to the prior measurement of 20/60.The inlay remains implanted at this time.At last examination, the patient presented with dry eye and mild blepharitis, but the surgeon anticipates a good outcome.

• 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: 7202632
• MDR Text Key: 97900208
• Report Number: 3005956347-2018-00012
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/28/2020
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2017
• 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: 58 YR