FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2011857
·
Received March 9, 2011
Report
- Report Number
- 2023826-2011-00198
- Event Type
- Injury
- Date Received
- March 9, 2011
- Date of Event
- February 7, 2011
- Report Date
- February 11, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - SURGICAL PROCEDURE, SECONDARY SURGERY. (B)(4) - LENS, VAULTING, LOW, EXPLANTED. DEVICE WAS NOT EVALUATED BY MANUFACTURER. DEVICE HAS NOT BEEN RETURNED. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). A WORK ORDER SEARCH REVEALED THERE WAS ONE SIMILAR COMPLAINT FOUND. (B)(4)
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A 12.6MM VICM 12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2011. THE LENS WAS EXPLANTED ON (B)(6) 2011 DUE TO LOW VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS. THE PATIENT'S POST-OP BCVA WAS 20/15.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | VICM 12.6 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention | INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK |