FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2492273
·
Received March 13, 2012
Report
- Report Number
- 2023826-2012-00187
- Event Type
- Injury
- Date Received
- March 13, 2012
- Date of Event
- November 22, 2011
- Report Date
- February 24, 2012
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A 13.0MM ICM130V4 IMPLANTABLE COLLAMER LENS IN THE PT'S LEFT EYE ON (B)(6) 2003. AN ANTERIOR SUBCAPSULAR CATARACT WAS NOTED ON (B)(6) 2011. THE LENS WAS EXPLANTED ON (B)(6) 2011, THE CATARACT WAS REMOVED AND A IOL LENS WAS IMPLANTED. THE PT'S LAST VISIT WAS ON (B)(6) 2012, BCVA WAS 20/25.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | ICM130V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |