FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 3080603
·
Received April 26, 2013
Report
- Report Number
- 2023826-2013-00315
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- November 24, 2012
- Report Date
- April 5, 2013
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. SIZE INCORRECT FOR PATIENT.(B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2013 DUE TO LOW VAULTING. THE ICL WAS EXCHANGED FOR A LONGER LENS WHICH RESOLVED THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182625 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | ICM115V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention | CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK |