MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-25 for LADAR6000 SYSTEM 8065990005 manufactured by Alcon - Orlando Technology Center.
[599093]
A system operator provided a spreadsheet of patient data for analysis and assistance in preparation of a platform presentation. Upon review of the data, this patient was found to exhibit an increase in mrse (manifest refraction spherical equivalent) in the right eye at the 6-week post-operative exam. Patient records have been received and indicate at 7 months post-op, this patient exhibits a decrease in bcva in both eyes. The right eye was reported under manufacturer report #1061857-2006-00222. This report is for the left eye. At the latest post-op exam, the left eye exhibited a 2-line decrease in bcva and an overcorrection of 2. 5 diopters. Ucva improved from 20/400 pre-op to 20/80.
Patient Sequence No: 1, Text Type: D, B5
[7955627]
The investigation, including root cause determination is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061857-2007-00177 |
| MDR Report Key | 844017 |
| Report Source | 05 |
| Date Received | 2007-04-25 |
| Date of Report | 2007-03-26 |
| Date of Event | 2006-07-14 |
| Date Mfgr Received | 2007-03-27 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2007-05-04 |
| 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 | LADAR6000 SYSTEM |
| Generic Name | OPHTHALMIC EXCIMER LASER SYSTEM |
| Product Code | DZS |
| Date Received | 2007-04-25 |
| Model Number | NA |
| Catalog Number | 8065990005 |
| Lot Number | NA |
| ID Number | 6.1.2 |
| 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 | 831191 |
| Manufacturer | ALCON - ORLANDO TECHNOLOGY CENTER |
| Manufacturer Address | 2501 DISCOVERY DRIVE SUITE 500 ORLANDO FL 32826 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-25 |