MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-16 for LADARVISION 4000 8065490006 manufactured by Alcon-orlando Technology Ctr.
[590343]
A system operator reports one custom hyperopic pt who is over corrected following lasik surgery. Pt records were provided and indicate this pt was treated for a monovision outcome, the right eye treated for distance. At approx 2 months post-op, this pt exhibited a decrease of 3 lines bcva in the right eye. Add'l info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[7939348]
A surgery database device report was conducted for this system and the analysis determined that the laser performance factors analyzed were operating within specification during the time of this pt's surgery.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061857-2007-00006 |
| MDR Report Key | 819773 |
| Report Source | 05 |
| Date Received | 2007-02-16 |
| Date of Report | 2007-01-09 |
| Date of Event | 2006-11-30 |
| Date Mfgr Received | 2007-01-15 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2007-02-26 |
| 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 | 2007-02-16 |
| Model Number | NA |
| Catalog Number | 8065490006 |
| Lot Number | NA |
| ID Number | 5.5.0 |
| 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 | 807256 |
| Manufacturer | ALCON-ORLANDO 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 | 8065490006 |
| Baseline ID | HOLLYWOOD 3.16 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-16 |