FDA Adverse Event
Injury
Summary report: N
RAINDROP NEAR VISION INLAY
MDR report key: 6990202
·
Received October 31, 2017
Report
- Report Number
- 3005956347-2017-00134
- Event Type
- Injury
- Date Received
- October 31, 2017
- Date of Event
- October 6, 2017
- Report Date
- October 31, 2017
- Manufacturer
- REVISION OPTICS, INC.
- Product Code
- LQE
- UDI-DI
- 10850394006013
- PMA / PMN Number
- P150034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. DEBRIS IN THE INTERFACE IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. (B)(4).
Description of Event or Problem · 1
THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. ONE WEEK POSTOPERATIVELY THE PATIENT PRESENTED WITH EXCESSIVE DEBRIS IN THE INTERFACE AND AN INFLAMMATORY RESPONSE. THE INLAY WAS EXPLANTED ON (B)(6) 2017; HOWEVER, THE SOURCE OF THE DEBRIS, SERIOUSNESS OF THE INFLAMMATION, AND IMPACT ON VISION ARE NOT KNOWN AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 769374 | RAINDROP NEAR VISION INLAY | CORNEAL INLAY | LQE | REVISION OPTICS, INC. | 610-0001 | 003071 | 10850394006013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP |