FDA Adverse Event
Other
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1056636
·
Received June 4, 2008
Report
- Report Number
- 2023826-2008-00770
- Event Type
- Other
- Date Received
- June 4, 2008
- Date of Event
- April 17, 2008
- Report Date
- May 7, 2008
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO INSERT A MICL13.2 IMPLANTABLE COLLAMER LENS AND THE LENS TORE WHILE ADVANCING IN THE CARTRIDGE. THERE WAS NO PT CONTACT. THIS IS ONE OF TWO ATTEMPTS TO INSERT THE LENS IN THIS PT. SEE MFR REPORT #2023826-2008-00769. THE REPORTER STATED THE INCIDENT WAS DUE TO A LOADING ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MICL13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | FOAM TIP PLUNGER MODEL| CARTRIDGE MODEL SFC-45 FP| INJECTOR MODEL MSI-TF |