FDA Adverse Event
Malfunction
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1912269
·
Received November 23, 2010
Report
- Report Number
- 2023826-2010-01192
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- October 22, 2010
- Report Date
- October 28, 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
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4): EVAL: METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF THE LENS OPTIC AND ONE HAPTIC TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON INSERTED A 13.2 MM MICL 13.2 IMPLANTABLE COLLAMER LENS AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MICL 13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | INJECTOR: MODEL MSI-PF -LOT # UNK| CARTRIDGE: MODEL SFC-45 FP -LOT # UNK| FOAM TIP PLUNGER MODEL FOAM TIP PLUNGER -LOT # UNK |