FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 8664800
·
Received June 3, 2019
Report
- Report Number
- 2023826-2019-00992
- Event Type
- Injury
- Date Received
- June 3, 2019
- Date of Event
- March 14, 2019
- Report Date
- May 6, 2019
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATION: LENS WAS RETURNED IN A MICRO CENTRIFUGE VIAL WITH MOISTURE ON THE LENS. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO THE LENS. CLAIM#: (B)(4).
Additional Manufacturer Narrative · 1
THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT A 12.6MM, VTICMO12.6, -12.5/4.5/096 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. ON (B)(6) 2019 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO OBSERVATION OF LOW VAULT. THIS EXCHANGE RESOLVED THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455621 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICMO 12.6 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |