MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-04-05 for MONARCH IOL DELIVERY SYSTEM - CARTRIDGE UNK manufactured by Alcon Laboratories, Inc./huntington.
[19166051]
A nurse at the user facility reported that during intraocular lens (iol) implantation, the lens did not fold/inject properly. During this procedure, an anterior vitrectomy was done. The lens was inserted using the iol delivery system. Add'l info has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2002-00123 |
| MDR Report Key | 386440 |
| Report Source | 05 |
| Date Received | 2002-04-05 |
| Date of Report | 2002-03-07 |
| Date Mfgr Received | 2002-03-07 |
| Date Added to Maude | 2002-04-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SHERRI LAKOTA |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175686179 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONARCH IOL DELIVERY SYSTEM - CARTRIDGE |
| Generic Name | LENS GUIDE |
| Product Code | LYB |
| Date Received | 2002-04-05 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 375474 |
| Manufacturer | ALCON LABORATORIES, INC./HUNTINGTON |
| Manufacturer Address | 6065 KYLE LANE HUNTINGTON WV 25702 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-04-05 |