MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-10 for RAINDROP NEAR VISION INLAY PP6-530-0027 manufactured by Revision Optics.
[96934169]
The corneal inlay had extruded through the flap and was not available for analysis. The device history record review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue. Corneal melting, corneal scarring, corneal inflammation, loss of vision, and increased visual symptoms are listed in the device labeling as known potential risks. Complaint reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[96934170]
The subject was enrolled in the u. S. Ide clinical trial and underwent implantation of the investigational raindrop corneal inlay in the left eye on (b)(6) 2013. Four years postoperatively the subject was diagnosed by an ophthalmologist (not the study investigator) with (b)(6) over the inlay and was prescribed steroids and antiviral medications for 2 weeks with no resolution. The patient was later seen by the ide investigator who did not confirm the diagnosis of (b)(6), but instead reported focal dense central scarring anterior and posterior to the inlay with melting of the stroma and disruption of the epithelium directly over the inlay with very poor vision. The patient was prescribed steroids and the inlay was scheduled to be explanted. During the intervention, the inlay was not removed because it had extruded through the flap. Additional information is being requested. In addition to the report from the study investigator, the study subject also contacted the manufacturer and reported experiencing ocular irritation, sensitivity to light, and eye tearing. The patient denies having a medical history of (b)(6), but disclosed he has allergies and admitted to eye rubbing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005956347-2018-00011 |
| MDR Report Key | 7181212 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-10 |
| Date of Event | 2017-10-13 |
| Date Mfgr Received | 2017-12-15 |
| Device Manufacturer Date | 2012-07-09 |
| Date Added to Maude | 2018-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. PUSHPITA SINGH |
| Manufacturer Street | 25651 ATLANTIC OCEAN DR., STE. A1 |
| Manufacturer City | LAKE FOREST CA 926308835 |
| Manufacturer Country | US |
| Manufacturer Postal | 926308835 |
| Manufacturer Phone | 9497072740 |
| Manufacturer G1 | REVISION OPTICS |
| Manufacturer Street | 25651 ATLANTIC OCEAN DR., STE. A1 |
| Manufacturer City | LAKE FOREST CA 926308835 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 926308835 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAINDROP NEAR VISION INLAY |
| Generic Name | CORNEAL INLAY |
| Product Code | LQE |
| Date Received | 2018-01-10 |
| Model Number | PP6-530-0027 |
| Lot Number | 002354 |
| Device Expiration Date | 2013-07-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REVISION OPTICS |
| Manufacturer Address | 25651 ATLANTIC OCEAN DR., STE. A1 LAKE FOREST CA 926308835 US 926308835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-01-10 |