FDA Adverse Event
Death
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 12132737
·
Received July 7, 2021
Report
- Report Number
- 2023826-2021-02375
- Event Type
- Death
- Date Received
- July 7, 2021
- Date of Event
- January 6, 2021
- Report Date
- June 7, 2021
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WEIGHT: UNK, ETHNICITY: UNK, RACE: UNK. THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT A 12.1MM, VICMO12.1, -9.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. ON (B)(6) 2021 THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS DUE TO LOW VAULT. IT WAS REPORTED THAT THE PROBLEM RESOLVED. UNKNOWN WAS REPORTED TO BE THE CAUSE OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1022910 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VICMO13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention |