MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-03-27 for LADARVISION 4000 8065490006 manufactured by Orlando Technology Center.
[455389]
Following lasik surgery, this pt exhibited an increase in mrse of. 63 diopters in the right eye at the 1 month post-operative exam. No further info is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061857-2006-00161 |
| MDR Report Key | 704956 |
| Report Source | 05 |
| Date Received | 2006-03-27 |
| Date of Report | 2005-09-27 |
| Date Mfgr Received | 2005-09-27 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2006-05-01 |
| 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 DRIVE SUITE 500 |
| Manufacturer City | ORLANDO FL 32826 |
| Manufacturer Country | US |
| Manufacturer Postal | 32826 |
| Manufacturer Phone | 4073841644 |
| Manufacturer G1 | ALCON - ORLANDO TECHNOLOGY CENTER |
| Manufacturer Street | 2501 DISCOVERY DRIVE SUITE 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 | 2006-03-27 |
| Model Number | NA |
| Catalog Number | 8065490006 |
| Lot Number | NA |
| ID Number | UNK |
| 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 | 694024 |
| Manufacturer | ORLANDO TECHNOLOGY CENTER |
| 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 | 8065490006 |
| Baseline ID | HOLLYWOOD 3.16 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-27 |