FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 18813436
·
Received February 29, 2024
Report
- Report Number
- 2023826-2024-00940
- Event Type
- Malfunction
- Date Received
- February 29, 2024
- Date of Event
- December 16, 2023
- Report Date
- January 30, 2024
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4)
Additional Manufacturer Narrative · 0
H11: MFR#: 2023826-2024-00940 WAS FOUND TO BE A DUPLICATE OF MFR#: 2023826-2024-00880. DISREGARD INITIAL MEDWATCH REPORT. CLAIM#: (B)(4).
Description of Event or Problem · 0
THE REPORTER INDICATED THAT A 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS OF A -4.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED FOR A LONGER LENGTH LENS DUE TO LOW VAULT. THE PROBLEM WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298281 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VICMO12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | CARTRIDGE MODEL: SFC-45 - LOT# UNK.| FOAM TIP PLUNGER - LOT# UNK.| INJECTOR MODEL: MSI-PF - LOT# UNK. |