N
Patient 1
THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).
MAUDE MDR 9869326
- MDR report key
- 9869326
- Report number
- 2023826-2020-00621
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-08-30
- Date received
- 2020-03-23
- 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 INTRAOCULAR LENS | STAAR SURGICAL COMPANY | MTA | VICMO13.2 | NA | NA | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-23 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS, -8.0 DIOPTER, INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXCHANGED WITH A SHORTER LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.