FDA Adverse Event
Malfunction
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 4167261
·
Received October 13, 2014
Report
- Report Number
- 2023826-2014-00797
- Event Type
- Malfunction
- Date Received
- October 13, 2014
- Date of Event
- May 19, 2014
- Report Date
- July 17, 2014
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: METHOD - LENS WORK ORDER SEARCH. RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC HAS A SMALL PIECE TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. CONCLUSIONS - (USER ERROR CAUSED EVENT): BASED ON THE COMPLAINT HISTORY, LENS WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, IT WAS DETERMINED THE MOST PROBABLE CAUSE OF LENS TEARING DURING INJECTOR WAS USER ERROR. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED AN VICM 13.2MM IMPLANTABLE COLLAMER LENS IN PATIENT'S RIGHT EYE ON (B)(4) 2014. THE LENS TORE DURING INSERTION INTO THE EYE. THE LENS WAS REMOVED AND EXCHANGED FOR ANOTHER SAME MODEL AND SIZE LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 646889 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VICM 13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | INJECTOR MODEL AND LOT NUMBER - UNK| CARTRIDGE MODEL AND LOT NUMBER - UNK| FOAM TIP PLUNGER MODEL AND LOT NUMBER - UNK |