FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2800987
·
Received October 18, 2012
Report
- Report Number
- 2023826-2012-00778
- Event Type
- Injury
- Date Received
- October 18, 2012
- Date of Event
- July 19, 2012
- Report Date
- September 20, 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
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED AN 12.0MM ICM1204 IMPLANTABLE COLLAMER LENS IN PT'S RIGHT EYE ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2012 DUE TO EXCESSIVE VAULTING ASSOCIATED WITH ELEVATED INTRAOCULAR PRESSURE, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, PUPIL BLOCK AND ANGLE CLOSURE. NO OTHER LENS WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | ICM120V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Required Intervention |