FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2153333
·
Received June 30, 2011
Report
- Report Number
- 2023826-2011-00593
- Event Type
- Injury
- Date Received
- June 30, 2011
- Date of Event
- May 27, 2011
- Report Date
- June 2, 2011
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL: LENS WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS IN THE PT'S RIGHT EYE ON (B)(6) 2011. ON (B)(6) 2011 THE LENS WAS REMOVED DUE TO EXCESSIVE VAULTING AND HIGH IOP. THERE WAS SHALLOWING OF THE ANGLE. THE INCISION WAS NOT WIDENED TO REMOVE THE LENS AND NO SUTURE WAS USED. DURING THIS PROCEDURE, NO OTHER LENS WAS IMPLANTED BECAUSE THE FACILITY DID NOT HAVE THE LENS THAT WAS NEEDED. ON (B)(6) 2011 A SHORTER LENS WAS IMPLANTED. SEE MFR'S 2023826-2011-00592 FOR LEFT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MICL12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention | INJECTOR: MODEL MSI-PF, LOT# UNK| CARTRIDGE: MODEL SFC-45 FP, LOT # UNK| FOAM TIP PLUNGER: MODEL, LOT# UNK |