FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6323476
·
Received February 10, 2017
Report
- Report Number
- 2023826-2016-01551
- Event Type
- Injury
- Date Received
- February 10, 2017
- Date of Event
- September 13, 2016
- Report Date
- October 13, 2016
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
PMA/510(K): NA THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S WORK ORDER SEARCH: NO ADDITIONAL SIMILAR COMPLAINT TYPE EVENTS WITHIN ASSOCIATED LOTS WERE FOUND. (B)(4). THIS IS A RESUBMISSION OF THE INITIAL MDR PER FDA REQUEST.
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS -17.0/+3.0/070 (SPHERE/CYLINDER/AXIS) DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S UNCORRECTED VISUAL ACUITY WAS 20/32.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107259 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICMO13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Unknown | Required Intervention |