FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 18007459
·
Received October 25, 2023
Report
- Report Number
- 2023826-2023-04779
- Event Type
- Malfunction
- Date Received
- October 25, 2023
- Date of Event
- September 22, 2023
- Report Date
- September 25, 2023
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- UDI-DI
- 00840311323111
- PMA / PMN Number
- P030016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CLAIM#: (B)(4).
Additional Manufacturer Narrative · 0
H6-INVESTIGATION TYPE 4110: LENS WORK ORDER SEARCH- NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. CLAIM#: (B)(4).
Description of Event or Problem · 0
THE REPORTER INDICATED THAT A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF -14.50/2.0/092 (SPHERE/CYLINDER/AXIS) LENS TEAR/BREAK DURING LOADING. THE LENS WAS NOT IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1838915 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICMO 12.6 | N/A | 00840311323111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Female | CARTRIDGE MODEL: SFC-45: LOT# UNK.| FOAM TIP PLUNGER (FTP), LOT# UNK.| INJECTOR MODEL: MSI-PF, LOT# UNK. |