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 2007-02-28 for LADARVISION 4000 8065490084 manufactured by Alcon - Alcon Technology, Ctr..
[591346]
An optometrist reports a 'low energy warning' error message at the end of the first procedure following the summer holiday. This was a conventional, epi-lasik procedure. Based on the info provided during the course of the investigation, at four mos post-op, this pt exhibited a 2-line decrease in bcva in the right eye. The surgeon indicated he and the pt was happy with the outcome; the pt work and functions well without corrective lenses. The surgeon also stated this was an expected result based on the pt's pre-op refraction.
Patient Sequence No: 1, Text Type: D, B5
[7940338]
The eval/investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061857-2007-00021 |
| MDR Report Key | 823163 |
| Report Source | 01,05,07 |
| Date Received | 2007-02-28 |
| Date of Report | 2006-08-17 |
| Date of Event | 2006-08-17 |
| Date Mfgr Received | 2007-01-29 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2007-03-06 |
| 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 | SHERRI LAKOTA |
| Manufacturer Street | 2501 DISCOVERY DR, STE 500 |
| Manufacturer City | ORLANDO FL 32826 |
| Manufacturer Country | US |
| Manufacturer Postal | 32826 |
| Manufacturer Phone | 4073841644 |
| Manufacturer G1 | ALCON-ORLANDO TECHNOLOGY CTR. |
| Manufacturer Street | 2501 DISCOVERY DR, STE 500 |
| Manufacturer City | ORLANDO FL 32826 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32826 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LADARVISION 4000 |
| Generic Name | OPHTHALMIC EXCIMER LASER SYSTEM |
| Product Code | DZS |
| Date Received | 2007-02-28 |
| Model Number | NA |
| Catalog Number | 8065490084 |
| Lot Number | NA |
| ID Number | 5.14 |
| 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 | 810571 |
| Manufacturer | ALCON - ALCON TECHNOLOGY, CTR. |
| Manufacturer Address | 2501 DISCOVERY DR. STE 500 ORLANDO FL 32826 US |
| Baseline Brand Name | LADARVISION 4000 |
| Baseline Generic Name | OPHTHALMIC EXCIMER LASER SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 8065490084 |
| Baseline ID | 5.11 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-28 |