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 Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

The explanted device has not been returned to the manufacturer at this time.The site is being contacted to determine whether it is still available for analysis.The device identifiers have been requested from the facility.Inlay shifts in position is listed in the device labeling as a known potential risk.(b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay on (b)(6) 2017.Postoperatively, the inlay has slightly decentered.The surgeon planned to explant the inlay late (b)(6) 2017.Additional information has been 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: 7162971
• MDR Text Key: 96712397
• Report Number: 3005956347-2018-00004
• Device Sequence Number: 1
• Product Code: LQE
• 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: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 610-0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention