MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-21 for INTERLASE manufactured by .
[2220188]
Unsuccessful interlase (custom lasik) performed. During the left eye surgery, the flap was cut too thin to process. The operation was aborted, pt was examined the day following procedure, pt was finally informed of real complication 4 days later. Excimer laser products were used, unsure of makes and models. Surgery date was (b)(6) 2011. I am the patient just trying to provide due diligence, this is reported correctly. The surgery was performed at (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022772 |
| MDR Report Key | 2308689 |
| Date Received | 2011-10-21 |
| Date of Report | 2011-10-21 |
| Date of Event | 2011-10-14 |
| Date Added to Maude | 2011-10-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERLASE |
| Generic Name | NONE |
| Product Code | LQJ |
| Date Received | 2011-10-21 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-21 |