N
Patient 1
THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4). NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).
MAUDE MDR 9881022
- MDR report key
- 9881022
- Report number
- 2023826-2020-00659
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-07-23
- Date received
- 2020-03-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. CYNTHIA THAI
- Address
- 1911 WALKER AVENUE MONROVIA, CA US
- Phone
- 303-303-3037
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | STAAR SURGICAL COMPANY | QCB | VTICMO13.7 | NA | NA | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-25 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM VTICMO13.7 IMPLANTABLE COLLAMER LENS, -8.5/+1.5/084 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD), ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO PATIENT EXPERIENCED GLARE AND HALOS. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE CAUSE OF THE EVENT WAS DUE TO PATIENT RELATED FACTOR.