FDA Adverse Event
Malfunction
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 3170979
·
Received June 14, 2013
Report
- Report Number
- 2023826-2013-00486
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 28, 2013
- Report Date
- May 29, 2013
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN, WITH A PIECE TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. (B)(4).
Additional Manufacturer Narrative · 1
AGE AT TIME OF EVENT - (B)(6). (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) AND THE HAPTIC TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS DUE TO OVERLOAD OF VISCOAT AND WAS NOT PRODUCT RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270559 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | MICL 12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | INJECTOR MODEL MSI-PF - LOT NUMBER UNK| INJECTOR LOT NUMBER 1239099| CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER LOT NUMBER 1279506| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| CARTRIDGE LOT NUMBER 1271959 |