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 Corneal Clouding/Hazing (1878); Loss of Vision (2139)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was discarded by the facility 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.Corneal haze and decreased vision are listed in the device labeling as known potential risks.Please reference mfr report # 3005956347-2017-00136 for the replacement inlay serial# (b)(4).(b)(4).

Event Description

The patient underwent uneventful implantation of the raindrop corneal inlay in the left eye on (b)(6) 2017.It should be noted that lasik surgery was performed on this eye concurrent with inlay implantation.One month postoperatively the inlay was removed and replaced with another raindrop inlay due to corneal haze.On (b)(6) 2017, the patient presented with 1+ peripheral corneal haze in the operative eye.The haze persisted throughout the postoperative period and was associated with glare and halos, the severity of which is not known.In addition, the patient's best corrected distance visual acuity (bcdva) decreased from 20/15-1 (preoperatively) to 20/30- at onset, improving to 20/20-2 immediately before explant on (b)(6) 2017.At last examination on (b)(6) 2017, bcdva improved to 20/20 with residual trace haze, but the halos persisted.According to the surgeon, the replacement inlay (implanted on (b)(6) 2017) had a "chip" which he believes caused inflammation.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: 7011907
• MDR Text Key: 91419063
• Report Number: 3005956347-2017-00135
• 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: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/02/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2016
• 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
• Patient Outcome(s): Congenital Anomaly; Required Intervention
• Patient Age: 62 YR