FDA Adverse Event
Injury
Summary report: N
VISION ICL IMPLANTABLE COLLAMER LENS
MDR report key: 730933
·
Received June 30, 2006
Report
- Report Number
- 2023826-2006-00915
- Event Type
- Injury
- Date Received
- June 30, 2006
- Report Date
- June 2, 2006
- Manufacturer
- STAAR SURGICAL
- Product Code
- HQL
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THAT THE SURGEON IMPLANTED A VISIAN ICL (IMPLANTABLE COLLAMER LENS MODEL MICL 13.2 ON 05/25/2006 AND EXPLANTED THE LENS AT A LATER DATE DUE TO THE MICL HAVING AN EXCESSIVE VAULT. THE PATIENT WAS EXPERIENCING AN INCREASED INTRAOCULAR PRESSURE AND PUPILLARY BLOCKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISION ICL IMPLANTABLE COLLAMER LENS | INTRAOCULAR LENS | HQL | STAAR SURGICAL | MICL13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention | CARTRIDGE MODEL: UNK, LOT NUMBER: UNK| INJECTOR MODEL: UNK, LOT NUMBER: UNK |