FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 17657029
·
Received August 30, 2023
Report
- Report Number
- 2023826-2023-03758
- Event Type
- Injury
- Date Received
- August 30, 2023
- Date of Event
- June 26, 2023
- Report Date
- August 5, 2023
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- 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
B5 - "INTO THE PATIENT'S LEFT EYE (OS)" SHOULD BE CORRECTED TO "INTO THE PATIENTS RIGHT EYE (OD)".
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VICMO12.1 IMPLANTABLE COLLAMER LENS OF DIOPTER -8.5 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LONGER LENGTH LENS DUE TO LOW VAULT AND THIS RESOLVED THE PROBLEM. CAUSE REPORTED AS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1438001 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VICMO12.1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Female | Required Intervention | CARTRIDGE MODEL: SFC-45: LOT# UNK.| FOAM TIP PLUNGER (FTP), LOT# UNK.| INJECTOR MODEL: MSI-PF, LOT# UNK. |