FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1901428
·
Received November 3, 2010
Report
- Report Number
- 2023826-2010-01100
- Event Type
- Injury
- Date Received
- November 3, 2010
- Date of Event
- August 31, 2010
- Report Date
- October 5, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) (SECONDARY) .(EXCESSIVE).
Description of Event or Problem · 1
THE REPORTER STATED THAT THE SURGEON IMPLANTED THE MICL13.2 IMPLANTABLE COLLAMER LENS ON (B)(6) 2010 AND THE LENS WAS EXPLANTED ON (B)(6) 2010 BECAUSE IT WAS TOO LONG. A SHORTER LENS WAS IMPLANTED AND THE PT IS DOING FINE. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF A MISMEASUREMENT AND NOT RELATED TO THE LENS. THIS REPORT IS FOR THE LEFT EYE. SEE MFR REPORT # 2023826-2010-01099 FOR THE RIGHT.
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 | 26 YR | Required Intervention | CARTRIDGE: MODEL SFC-45FP, LOT NUMBER: UNK| FOAM TIP PLUNGER: MODEL UNK, LOT NUMBER: UNK| INJECTOR: MODEL MSI-PF, LOT NUMBER - UNK |