FDA Adverse Event
Malfunction
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 3103480
·
Received May 9, 2013
Report
- Report Number
- 2023826-2013-00335
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 16, 2013
- Report Date
- April 16, 2013
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PT WEIGHT: UNK (B)(4). EVALUATION CODES: 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 A PIECE OF ONE HAPTIC TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. CLAIM # (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED A POSSIBLE CAUSE OF THE EVENT WAS DUE TO A LOADING ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204336 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | MICL 12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| INJECTOR MODEL MSI-PF - LOT NUMBER UNK |