FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 19168795
·
Received April 23, 2024
Report
- Report Number
- 2023826-2024-01555
- Event Type
- Injury
- Date Received
- April 23, 2024
- Date of Event
- January 24, 2024
- Report Date
- April 23, 2024
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
QCB- PHAKIC TORIC INTRAOCULAR LENS. CLAIM#(B)(4).
Additional Manufacturer Narrative · 0
H6: OFF-LABEL; ACD < 3.00MM AT THE TIME OF IMPLANTATION. CLAIM# (B)(4).
Additional Manufacturer Narrative · 0
CORRECTED DATA: B2: DISABILITY OR PERMANENT DAMAGE SHOULD BE OMITTED FOR CORRECTION. CLAIM# (B)(4).
Description of Event or Problem · 0
THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1MM VICMO_12.1; -9.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. THE LENS WAS REPORTED AS HAVING LOW VAULT WITHOUT ROTATION. CAUSE OF THE EVENT WAS UNKNOWN. ON (B)(6) 2024 THE LENS WAS REPLACED WITH A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1381848 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VICMO 12.1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Unknown | Required Intervention| S | CARTRIDGE MODEL:UNK, LOT# UNK.| FOAM TIP PLUNGER (FTP), LOT# UNK.| INJECTOR MODEL:UNK, LOT# UNK. |