FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2425873
·
Received January 16, 2012
Report
- Report Number
- 2023826-2012-00028
- Event Type
- Injury
- Date Received
- January 16, 2012
- Date of Event
- November 25, 2011
- Report Date
- January 10, 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 13.2 MM VICM13.2 IMPLANTABLE COLLAMER LENS IN THE PT'S LEFT EYE ON (B)(6) 2011. THE LENS WAS EXPLANTED ON (B)(6) 2011, DUE TO REFRACTIVE SURPRISE. THE PT EXPERIENCED ELEVATED IOP, GLARE AND HALOS. THE LENS WAS EXCHANGED FOR A SAME LENGTH BUT DIFFERENT DIOPTER SIZE LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL, CO. | VICM13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention |