FDA Adverse Event
Other
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1100205
·
Received July 31, 2008
Report
- Report Number
- 2023826-2008-01010
- Event Type
- Other
- Date Received
- July 31, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 2, 2008
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO LENS IN UNIT CARTON.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO INSERT A MICL12.6 IMPLANTABLE COLLAMER LENS AND NOTED IT WAS TURNING WHILE ADVANCING IN THE INJECTOR. THERE WAS PATIENT CONTACT BUT THE LENS WAS NOT IMPLANTED. NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | MICL12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INJECTOR MODEL MSI-PF LOT NUMBER UNKNOWN| CARTRIDGE MODEL SFC-25 FP| FOAM TIP PLUNGER MODEL |