FDA Adverse Event
Malfunction
Summary report: N
KS-3AI
MDR report key: 6970597
·
Received October 23, 2017
Report
- Report Number
- 2023826-2017-01607
- Event Type
- Malfunction
- Date Received
- October 23, 2017
- Date of Event
- September 26, 2017
- Report Date
- September 27, 2017
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4).
Additional Manufacturer Narrative · 1
ADDITIONAL DATA: DEVICE EVALUATION: THE DELIVERY SYSTEM WAS RETURNED IN A DEVICE TRAY AND HAD CLEAR SURGICAL RESIDUE/ DEBRIS ON THE PRODUCT. VISUAL INSPECTION FOUND THE LENS STUCK IN THE INJECTOR AND PRESENCE OF WHITE AND CLEAR SURGICAL RESIDUE ON THE DEVICE. CLAIM# (B)(4).
Additional Manufacturer Narrative · 1
CORRECTED DATA: COMMON DEVICE NAME: IT IS CORRECTED TO "INTRAOCULAR LENS, PRODUCT CODE: HQL". CLAIM#: (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A KS-3AI, 20.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE ON (B)(6) 2017. BEFORE IMPLANTATION, THE LENS GOT STUCK IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT WITH DEVICE. THE SURGEON DECIDED TO USE A BACK-UP LENS, WHICH WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 749445 | KS-3AI | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | KS-3AI | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |