VISIAN ICL (IMPLANTABLE COLLAMER LENS)
Report
- Report Number
- 2023826-2012-00123
- Event Type
- Injury
- Date Received
- February 23, 2012
- Report Date
- January 10, 2012
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4).
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 11.5MM ICM115V4, -18.00 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2011. THE LENS WAS REMOVED AND REPLACED ON (B)(6) 2012 FOR A LONGER LENGTH LENS DUE TO LOW VAULT. THIS RESOLVED THE PROBLEM. REPORTER STATED "DESPITE THE FACT THAT OUR PATIENT HAS A VERY LOW VAULT, SUBJECTIVELY IS FINE." (B)(4).
(B)(4).
THE REPORTER STATED THE SURGEON IMPLANTED LENS IN THE PT'S LEFT EYE AND LOW VAULTING. LENS SERIAL NUMBER AND MODEL WERE NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. FURTHER INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL WILL BE SUBMITTED WHEN FURTHER INFORMATION IS AVAILABLE.
ADDITIONAL INFORMATION: THE REPORTER STATED THE SURGEON IMPLANTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE ON (B)(6) 2011. SURGERY IS PENDING TO REMOVE AND EXCHANGED THE LENS DUE TO SHALLOW VAULT. THE LENS REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | ICM115V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |