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 LADARVISION 8065490006 manufactured by Alcon - Orlando Technology Center.
[620040]
A surgeon reports a patient that is overcorrected following refractive surgery. Patient records were provided and indicate at 6 months post-op, this patient exhibited a 1d overcorrection in the left eye and bcva in the left eye decreased from 20/20 pre-op to 20/25. An enhancement was performed 8 months following the initial procedure. At approximately 6 weeks post-enhancement, the overcorrection had resolved; however, bcva was now 20/40. Ucva improved from 20/cf pre-op to 20/50-2 at 6-weeks post-enhancement.
Patient Sequence No: 1, Text Type: D, B5
[7867298]
Determination of root cause: assessment: a surgery database performance verification was conducted on this system. The analysis indicated the laser performance factors analyzed were operating within specification during this patient's surgeries. Patient records were reviewed for non-product factors including patient response to the later ablation, patient healing characteristics and preoperative patient selection. No specific non-product factors could be identified or the initial overcorrection noted. Following the enhancement, the records indicate postoperative complications for the left eye indicating a flap lift-refloat and refractive instability. The records do not indicate any potential contributing factors for the decreased bcva in the left eye; however, pre-enhancement measurements as well as the post-enhancement topographies suggest a thin cornea for the left eye. It is not uncommon for the cornea to demonstrate a hyperopic-astigmatic refractive error secondary to corneal thinning. Conclusion: based on the results of the investigation of product and non-product factors, the device was not found to be a contributor to the decrease in bcva. However, the non-product related factors mentioned above may have been contributors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061857-2007-00173 |
| MDR Report Key | 844007 |
| Report Source | 05 |
| Date Received | 2007-04-25 |
| Date of Report | 2006-12-06 |
| Date of Event | 2006-02-23 |
| Date Mfgr Received | 2007-03-14 |
| Device Manufacturer Date | 2000-10-01 |
| 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 | LADARVISION |
| Generic Name | OPHTHALMIC EXCIMER LASER SYSTEM |
| Product Code | DZS |
| Date Received | 2007-04-25 |
| 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 | 831178 |
| 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 |