MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-28 for LADARVISION 4000 8065490084 manufactured by Alcon - Orlando Technology Center.
[590766]
A system operator reports one custom patient with an overcorrection post-op. Patient records provided indicate at approximately 3. 5 months post-op, this patient was overcorrected by. 75 diopters in the left eye. During the investigation, it was found that this patient also exhibited a 2-line decrease in bcva in the left eye and both eyes exhibited a slight increase in astigmatism; -1 diopter in the right eye and -. 75 diopters in the left eye.
Patient Sequence No: 1, Text Type: D, B5
[7824802]
A system performance verification was performed on this system. Analysis indicates the system was operating within specifications for the recorded parameters during the time of this patient's surgery. Determination of root cause: assessment: the conclusion of the device investigation indicates the system performed within specifications during this patient's surgery. Non-product factors including patient response to the laser ablation, patient healing characteristics and preoperative patient selection were reviewed. In this case, specific non-product factors that could have contributed to the loss of bcva for the os could not be determined. No comments or explanations were documented by the site nor were additional tests (such as pin-hole acuity) were performed to confirm or deny the loss of bcva. In regards to the induced astigmatism for both eyes, postoperative topographies were not provided to determine the cause of the induced astigmatism, therefore specific non-product factors could not be determined. For the. 75d overcorrection noted for the os, no specific non-product factors could be determined. Conclusion: based on the information provided, an individual patient response and healing characteristics may have contributed to the outcomes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061857-2007-00022 |
| MDR Report Key | 824050 |
| Report Source | 05 |
| Date Received | 2007-02-28 |
| Date of Report | 2006-11-29 |
| Date of Event | 2006-10-06 |
| Date Mfgr Received | 2007-01-29 |
| Device Manufacturer Date | 2001-11-01 |
| Date Added to Maude | 2007-03-08 |
| 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 | 5.5.0 |
| 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 | 811452 |
| Manufacturer | ALCON - ORLANDO TECHNOLOGY CENTER |
| Manufacturer Address | 2501 DISCOVERY DRIVE SUITE 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 |