FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2051404
·
Received April 7, 2011
Report
- Report Number
- 2023826-2011-00305
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- March 11, 2011
- Report Date
- April 5, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - SECONDARY SURGERY, LOW, LENS ROTATION. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED AN 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN THE PT'S RIGHT EYE ON (B)(6) 2011. THE LENS WAS EXPLANTED ON (B)(6) 2011 DUE TO LOW VAULTING AND LENS ROTATION. THE LENS WAS EXCHANGED FOR A LONGER LENS. SEE MFR# 2023826-2011-00304 FOR LEFT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | ICM115V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention | INJECTOR: MODEL AND LOT NUMBER - UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNK| CARTRIDGE: MODEL AND LOT NUMBER - UNK |