FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 4183042
·
Received October 17, 2014
Report
- Report Number
- 2023826-2014-00842
- Event Type
- Injury
- Date Received
- October 17, 2014
- Date of Event
- July 23, 2014
- Report Date
- September 19, 2014
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PT WEIGHT: UNK. (B)(4). THE LENS REMAINS IMPLANTED.
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A VICM 13.2MM IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE ON (B)(6) 2014. THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. THE LENS REMAINS IMPLANTED. ON THE PATIENT'S LAST DOCTOR VISIT UCVA: 20/50.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661936 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VICM13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention | CARTRIDGE MODEL AND LOT NUMBER - UNK| INJECTOR MODEL AND LOT NUMBER - UNK| FOAM TIP PLUNGER AND LOT NUMBER - UNK |