FDA Adverse Event
Malfunction
Summary report: N
RAINDROP NEAR VISION INLAY
MDR report key: 6967215
·
Received October 20, 2017
Report
- Report Number
- 3005956347-2017-00127
- Event Type
- Malfunction
- Date Received
- October 20, 2017
- Date of Event
- September 22, 2017
- Report Date
- October 20, 2017
- Manufacturer
- REVISION OPTICS, INC.
- Product Code
- LQE
- UDI-DI
- 10850394006013
- PMA / PMN Number
- P150034
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
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. INLAY SHIFT IN POSITION IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. COMPLAINT REFERENCE #: (B)(4).
Description of Event or Problem · 1
THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE RIGHT EYE ON (B)(6) 2017. ONE-DAY POSTOPERATIVELY INLAY REPOSITIONING WAS ATTEMPTED DUE TO PRESUMED DECENTRATION. DURING REPOSITIONING THE INLAY WAS INADVERTENTLY RINSED OUT OF THE EYE AND A NEW INLAY WAS IMPLANTED. ADDITIONAL INFORMATION IS BEING REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745153 | RAINDROP NEAR VISION INLAY | CORNEAL INLAY | LQE | REVISION OPTICS, INC. | 610-0001 | 003132 | 10850394006013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |