FDA Adverse Event
Other
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1592147
·
Received January 28, 2010
Report
- Report Number
- 2023826-2010-00082
- Event Type
- Other
- Date Received
- January 28, 2010
- Date of Event
- January 4, 2010
- Report Date
- January 4, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) (LENS INSERTED UPSIDE DOWN) - (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MICL13.2 IMPLANTABLE COLLAMER LENS WAS MISLOADED AND INADVERTED INSERTED UPSIDE DOWN. THE LENS WAS REMOVED AND THE BACK UP LENS WAS IMPLANTED WITHOUT ANY PATIENT INJURY.
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 | 27 YR | INJECTOR: MODEL #MSI-PF, LOT #UNK| FOAM TIP PLUNGER: LOT #UNK| CARTRIDGE: MODEL #SFC-45 FP, LOT #UNK |