FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1901427
·
Received November 2, 2010
Report
- Report Number
- 2023826-2010-01097
- Event Type
- Injury
- Date Received
- November 2, 2010
- Report Date
- October 6, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN THE PT'S RIGHT EYE ON (B)(6) 2010. DUE TO REFRACTIVE SURPRISE, POSSIBLY THE LENS WILL BE EXPLANTED. THE LENS REMAINS IMPLANTED. THE REPORTER STATED THIS INCIDENT WAS DUE TO CALCULATIONS AND WAS NOT LENS RELATED. PT HAS PERIPHERAL LENS OPACITIES, REPORTER STATED NOT SIGNIFICANT. PT'S LAST VISIT ON (B)(6) 2010, BCVA 20/20.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | ICM125V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | FOAM TIP PLUNGER: MODEL UNK, LOT NUMBER: UNK| CARTRIDGE MODEL: SFC-45 FP, LOT NUMBER: UNK| INJECTOR: MODEL UNK, LOT NUMBER: UNK |