FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2921701
·
Received January 15, 2013
Report
- Report Number
- 2023826-2013-00052
- Event Type
- Injury
- Date Received
- January 15, 2013
- Date of Event
- October 18, 2012
- Report Date
- December 24, 2012
- 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).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED AN 12.5MM ICM125V IMPLANTABLE COLLAMER LENS IN PT'S RIGHT EYE ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2012 DUE TO EXCESSIVE VAULT ASSOCIATED WITH ELEVATED INTRAOCULAR PRESSURE. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. PT'S LAST VISIT ON (B)(6) 2012, UCVA WAS 20/25.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22123 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | ICM125V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention |