FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 18726381
·
Received February 16, 2024
Report
- Report Number
- 2023826-2024-00680
- Event Type
- Injury
- Date Received
- February 16, 2024
- Date of Event
- April 15, 2023
- Report Date
- February 7, 2024
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A4-A6: UNK. CLAIM # (B)(4).
Description of Event or Problem · 0
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM VTICM5 13.7 IMPLANTABLE COLLAMER LENS OF DIOPTER -8.5/1.5/086 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) (B)(6) 2023. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 529177 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICM5 13.7 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female | Required Intervention | CARTRIDGE MODEL: SFC-45 - LOT# 1661524.| FOAM TIP PLUNGER - LOT# UNK.| INJECTOR MODEL: MSI-TF - LOT# 1631496. |