MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2001-01-05 for 2500 LE ND: YAG LASER manufactured by Alcon - Irvine Technology Center.
[236398]
Reporter noted unit calibrated fine and there were no error messages, but felt laser was pitting lenses, requested focus and aiming check. No pt injury, no visual acuity lost.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2001-00008 |
| MDR Report Key | 311777 |
| Report Source | 05,07 |
| Date Received | 2001-01-05 |
| Date of Report | 2000-12-07 |
| Date of Event | 2000-12-07 |
| Date Mfgr Received | 2000-12-07 |
| Date Added to Maude | 2001-01-12 |
| 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 | NED LUCE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175686470 |
| 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 | 2500 LE ND: YAG LASER |
| Generic Name | LASER PHOTODISRUPTOR |
| Product Code | LXS |
| Date Received | 2001-01-05 |
| Model Number | 2500 LE |
| Catalog Number | 2500 LE |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 301562 |
| Manufacturer | ALCON - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US |
| Baseline Brand Name | 2500 LE ND:YAG LASER |
| Baseline Generic Name | LASER PHOTODISRUPTER |
| Baseline Model No | 2500 LE |
| Baseline Catalog No | 2500 LE |
| Baseline ID | NA |
| Baseline Device Family | P-DISRUPTER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K882772 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-01-05 |