FDA Adverse Event
Malfunction
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2180769
·
Received May 5, 2011
Report
- Report Number
- 2023826-2011-00378
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 7, 2011
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD: WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RETURNED IN LIQUID AND PIECES OF THE HAPTIC WERE MISSING. A WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION: NO CONCLUSION CAN BE DRAWN. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND PRODUCT EVAL, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THAT THE HAPTIC OF A MICL13.2 IMPLANTABLE COLLAMER LENS BENT AND THE SURGEON WAS INSERTING THE LENS. THE LENS WAS REMOVED WITHOUT ENLARGING THE INCISION AND THE BACK UP LENS WAS IMPLANTED. THE CAUSE OF THE INCIDENT WAS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MICL13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NAVIJET INJECTION SYSTEM, LOT NUMBER UNK |