MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2005-06-03 for EYELIT LASER EYELITE 8065500001 manufactured by Alcon - Irving Technology Center.
[416061]
Additional information received noted outcome of event was excellent.
Patient Sequence No: 1, Text Type: D, B5
[426430]
During surgery for retinal tear, felt laser delivered beam at a much higher power than initially set; close to 2 w instead of 220/250 mw. Pt had non-serious choroidal hemorrhage, which resolved itself. Incident didn't recur after settings were changed to a lower power 230 mw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2005-00085 |
| MDR Report Key | 617794 |
| Report Source | 01,05,07 |
| Date Received | 2005-06-03 |
| Date of Report | 2005-05-06 |
| Date of Event | 2005-05-04 |
| Date Mfgr Received | 2005-05-06 |
| Date Added to Maude | 2005-06-29 |
| 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 | 0 |
| Manufacturer Contact | CHARLES DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 8175518317 |
| Manufacturer G1 | ALCON - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EYELIT LASER |
| Generic Name | LASERS |
| Product Code | HQB |
| Date Received | 2005-06-03 |
| Model Number | EYELITE |
| Catalog Number | 8065500001 |
| Lot Number | NA |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 607482 |
| Manufacturer | ALCON - IRVING TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PKWY. IRVINE CA 92618 US |
| Baseline Brand Name | EYELITE LASER |
| Baseline Generic Name | LASER PHOTOCOGULATOR |
| Baseline Model No | EYELITE |
| Baseline Catalog No | 8065500001 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-03 |