FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6052746
·
Received October 24, 2016
Report
- Report Number
- 2023826-2016-01079
- Event Type
- Injury
- Date Received
- October 24, 2016
- Date of Event
- March 19, 2016
- Report Date
- June 14, 2016
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: LENS WAS RETURNED DRY IN LENS CASE/VIAL. CLEAR SURGICAL RESIDUE/DEBRIS WAS PRESENT ON THE PRODUCT. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO THE LENS. DIMENSIONAL INSPECTION FOUND THAT THE LENS MEASUREMENTS WERE WITHIN SPECIFICATIONS. WORK ORDER SEARCH: NO SIMILAR COMPLAINTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. 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 THAT THE SURGEON INSERTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -10.00/+2.0/092 DIOPTER, IN THE PATIENT'S RIGHT EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING AND A SHALLOW CHAMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701866 | ICL (IMPLANTABLE COLLAMER LENS) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VTICMO12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |