FDA Adverse Event
Malfunction
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1083161
·
Received July 24, 2008
Report
- Report Number
- 2023826-2008-00995
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Report Date
- July 2, 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
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND.
Description of Event or Problem · 1
THE RPTR STATED THE SURGEON IMPLANTED A 12.6 MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN 2007. THE REPORTER STATED IT IS PLANNED TO EXPLANT THE LENS AND EXCHANGE FOR A LONGER LENS DUE TO WHEN THE PT PUSHES TEMPORARILY ON HIS EYE, HIS VISION STRAIGHTENS OUT AND HE CAN SEE. ADD'L INFO HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MICL 12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CARTRIDGE MODEL AND LOT # UNK| FOAM TIP PLUNGER MODEL AND LOT # UNK| INJECTOR MODEL AND LOT# UNK |