FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 8271129
·
Received January 23, 2019
Report
- Report Number
- 2023826-2019-00172
- Event Type
- Injury
- Date Received
- January 23, 2019
- Date of Event
- November 2, 2017
- Report Date
- December 26, 2018
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
CORRECTED DATA: CORRECTED TO: PHAKIC TORIC INTRAOCULAR LENS, PRODUCT CODE: QCB DEVICE EVALUATION: LENS WAS RETURNED DRY, IN A MICRO-CENTRIFUGE VIAL. THERE WAS CLEAR SURGICAL RESIDUE ON PRODUCT. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO LENS AND PRESENCE OF RESIDUE ON LENS SURFACE. 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 THE SURGEON IMPLANTED A 12.6MM, VTICMO12.6, -15.50/3.0/086 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2017. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO OBSERVATION OF LOW VAULT WITH ROTATION. THIS EXCHANGE RESOLVED THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64169 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICMO12.6 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |