FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2984222
·
Received February 28, 2013
Report
- Report Number
- 2023826-2013-00180
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- December 23, 2012
- Report Date
- January 30, 2013
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON IMPLANTED THE VICM12.6 IMPLANTABLE COLLAMER LENS ON (B)(6) 2012 AND ANGLE CLOSURE WITH ELEVATED IOP ASSOCIATED WITH EXCESSIVE VAULT WAS NOTED. PATIENT EXPERIENCED SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, PUPIL BLOCK, PIGMENT DISPERSION AND UNREATIVE PUPIL. THERE WAS A LOSS OF BCVA (20/50). THE LENS WAS REMOVED ON (B)(6) 2012 AND REPLACED WITH A SHORTER LENGTH LENS AND THIS RESOLVED THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85889 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VICM12.6 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |