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 2006-07-10 for LADARVISION 4000 80650440601 manufactured by Alcon-orlando Technology Ctr.
[524606]
An od reports "unpredictable outcomes on a few pts", both custom and conventional. Clinical records for 12 pts were received and reviewed. Two pts were found to have reportable events due to over corrections. The other pt is being reported under mdr #1061857-2006-00208. During the early post-operative period, the pt reported monocular double vision, blurry vision in the left eye, and difficulty with intermediate vision. At one year post-op, the pt showed an over correction of 3. 00 diopters in the right eye and 2. 50 diopters the left eye. Bcva remained basically the same compared to pre-op.
Patient Sequence No: 1, Text Type: D, B5
[7833358]
The investigation has not been completed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061857-2006-00214 |
| MDR Report Key | 747359 |
| Report Source | 01,05,07 |
| Date Received | 2006-07-10 |
| Date of Report | 2006-07-10 |
| Date Mfgr Received | 2006-07-10 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2006-08-15 |
| 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 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 DR 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 | 2006-07-10 |
| Model Number | NA |
| Catalog Number | 80650440601 |
| 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 | 735133 |
| Manufacturer | ALCON-ORLANDO TECHNOLOGY CTR |
| Manufacturer Address | 2501 DISCOVERY DR STE 500 ORLANDO FL 32826 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-07-10 |