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

Model Number PP6-530-0027-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

The inlay remains implanted and therefore 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.(b)(4).The inlay remains implanted.

Event Description

The subject was enrolled in the ide clinical trial and underwent uneventful implantation of the investigational corneal inlay in the right eye on (b)(6) 2012.The patient followed the study protocol as directed.Five years postoperatively, the patient presented with central corneal haze, grade ii in the operative eye.The patient's best corrected distance visual acuity (bcdva) decreased from 55 letters (preoperatively) to 38 at onset.The patient is being treated with topical steroids and the haze has improved slightly.At last examination on (b)(6) 2017, bcdva was 20/100, however this is confounded because the patient is developing cataracts.

Manufacturer Narrative

The explanted inlay was discarded by the facility and is not available for evaluation.(b)(4).

Event Description

The inlay was explanted on (b)(6) 2017 in order to address recurrent haze.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

Clarification for the reported event was requested from the surgeon, who provided the following additional information.At last examination on (b)(6) 2017, bcdva was 20/25+.

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

Patient follow-up was requested from the surgeon, who provided the following additional information.The patient presented with central and peripheral grade 2 haze at the 60 month follow-up visit.The patient had no prior relevant medical or ocular history.The patient was examined 1-day post inlay explant, at which time haze was still present.At last examination on (b)(6) 2017, bcdva was 20/40 (cataract present), but the status of the corneal haze was not provided.Additional information has been requested.The corneal inlay is not suspected as a contributing factor in the cataract progression (locs iii grading: opalescence/color - grade 3).The cataract will be addressed at a later time once the eye heals.

• 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: 6729179
• MDR Text Key: 80619948
• Report Number: 3005956347-2017-00072
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: G090149
• 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,Followup,Followup,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/01/2013
• Device Model Number: PP6-530-0027-US
• Device Lot Number: 002200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2011
• 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
• Patient Age: 68 YR