MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-14 for MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D 8065977763 manufactured by Alcon Research, Llc - Huntington.
[183104201]
Evaluation summary: the cartridge was not returned for analysis. The iol, case, and carton of the iol were returned. Cartridge complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183104202]
A facility representative reported a split cartridge. Additional information was provided by a materials manager, the initial reporter, that the procedure was completed without patient harm with a new iol and cartridge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00233 |
| MDR Report Key | 9710872 |
| Report Source | OTHER |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-14 |
| 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 - HUNTINGTON |
| Manufacturer Street | 6065 KYLE LANE |
| Manufacturer City | HUNTINGTON WV 25702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 25702 |
| 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, CARTRIDGE D |
| Generic Name | FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) |
| Product Code | MSS |
| Date Received | 2020-02-14 |
| Returned To Mfg | 2020-01-30 |
| Model Number | NA |
| Catalog Number | 8065977763 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - HUNTINGTON |
| Manufacturer Address | 6065 KYLE LANE HUNTINGTON WV 25702 US 25702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |