FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 8355980
·
Received February 20, 2019
Report
- Report Number
- 2023826-2019-00283
- Event Type
- Injury
- Date Received
- February 20, 2019
- Date of Event
- August 29, 2018
- Report Date
- December 21, 2018
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL DATA: DEVICE EVALUATION: THE LENS WAS RETURNED DRY IN A MICRO-CENTRIFUGE VIAL. VISUAL INSPECTION FOUND DEFORMED HAPTICS. CORRECTED DATA: PHAKIC TORIC INTRAOCULAR LENS, PRODUCT CODE: QCB CLAIM # (B)(4).
Additional Manufacturer Narrative · 1
THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, - 8.5/+1.5/078 (SPHERE/CYLINDER/AXIS) IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO LOW VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE EYE IS QUIET. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148209 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICM5_13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention | CARTRIDGE MODEL SFC-45 - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| INJECTOR MODEL MSI-PF - LOT NUMBER UNK |