MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-03 for MONARCH III IOL DELIVERY SYSTEM, INJECTOR 8065977773 manufactured by Alcon Research, Llc - Alcon Precision Device.
[185112785]
Evaluation summary: complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185112786]
A facility representative reported that during an intraocular lens (iol) implant procedure, after the lens was implanted, the doctor noticed a large scratch and cut out the lens and put in a new lens. The procedure was completed the same day. Additional information was received, that in the surgeon's opinion, the cause of the event, or what contributed to the event, may have been the lens loader. The lens loader was taken off of that tray to thoroughly clean. It was replaced with a new one. There are two medical device reports associated with this event. This report is associated with the lens loader/injector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523835-2020-00055 |
| MDR Report Key | 9780818 |
| Report Source | OTHER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | ALCON RESEARCH, LLC - ALCON PRECISION DEVICE |
| Manufacturer Street | 714 COLUMBIA AVENUE |
| Manufacturer City | SINKING SPRING PA 19608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONARCH III IOL DELIVERY SYSTEM, INJECTOR |
| Generic Name | LENS, GUIDE, INTRAOCULAR |
| Product Code | KYB |
| Date Received | 2020-03-03 |
| Model Number | III |
| Catalog Number | 8065977773 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - ALCON PRECISION DEVICE |
| Manufacturer Address | 714 COLUMBIA AVENUE SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |