FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE COLLAMER LENS
MDR report key: 8475388
·
Received April 2, 2019
Report
- Report Number
- 2023826-2019-00525
- Event Type
- Malfunction
- Date Received
- April 2, 2019
- Date of Event
- March 5, 2019
- Report Date
- March 8, 2019
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 1
THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT AS THE SURGEON REMOVED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -18.0/+4.0/091 (SPHERE/CYLINDER/AXIS), FROM THE LENS VIAL, HE REALIZED IT WAS TORN. THIS OCCURRED ON (B)(6) 2019 PRIOR TO THE LOADING PROCESS. THE LENS WAS SCHEDULED TO BE IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 266256 | IMPLANTABLE COLLAMER LENS | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICMO12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | CARTRIDGE MODEL-SFC-45, LOT#-UNK| FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK| INJECTOR MODEL-UNK, LOT#-UNK| CARTRIDGE MODEL-SFC-45, LOT#-UNK| FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK| INJECTOR MODEL-UNK, LOT#-UNK |