FDA Adverse Event
Other
Summary report: N
ALCON MONARCH INSERTER
MDR report key: 18782662
·
Received February 23, 2024
Report
- Report Number
- MW5151981
- Event Type
- Other
- Date Received
- February 23, 2024
- Manufacturer
- ALCON RESEARCH, LLC
- Product Code
- KYB
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE LENS WAS PLACED INTO THE INSERTER AND GIVEN TO THE SURGEON. WHEN SURGEON WAS ADVANCING THE LENS HALFWAY THROUGH SHE NOTED A SCRATCH ON THE LENS. SURGEON CONTINUED TO ADVANCE THE LENS STATING THAT DUE TO PATIENT'S EYE MEDICAL HISTORY THAT REMOVING THE LENS WOULD CAUSE MORE HARM. THE SCRUB SAID THAT SHE BELIEVES THAT THE TOP PORTION OF THE NOTCH THAT PUSHES THE LENS IN THE INSERTER WAS THE ONE THAT CAUSED THE SCRATCH. SURGEON USED LENS CUTTER TO REMOVE THE IMPLANT. NEW INTRAOCULAR LENS IMPLANT WAS PLACED. PROCEDURE WAS COMPLETED AND PATIENT WAS STABLE UPON TRANSFER TO PHASE 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103538 | ALCON MONARCH INSERTER | LENS, GUIDE, INTRAOCULAR | KYB | ALCON RESEARCH, LLC | 8065977774 | 14EOKW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |