FDA Adverse Event
Malfunction
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2893843
·
Received January 2, 2013
Report
- Report Number
- 2023826-2013-00001
- Event Type
- Malfunction
- Date Received
- January 2, 2013
- Date of Event
- November 20, 2012
- Report Date
- December 4, 2012
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RETURNED IN LIQUID AND A PIECE OF A HAPTIC WAS TORN OFF AND MISSING. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AS THE SURGEON WAS INSERTING THE MICL12.6 IMPLANTABLE COLLAMER LENS, THE TRAILING HAPTIC GOT STUCK ON THE PLUNGER OF THE INJECTOR AND TORE. THE LENS WAS REMOVED AND THE BACK UP LENS WAS IMPLANTED WITHOUT FURTHER INCIDENT. ONE SUTURE CLOSED THE WOUND. THE REPORTER STATED THE INCIDENT WAS DUE TO AN OPERATOR ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | MICL12.6 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |