MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-01 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.
[74120390]
Date of event: best estimate date (b)(6) 2017 is provided as the reporter has indicated the onset of symptoms occurred at one month post exam of initial procedure. No patient code available for overcorrection. The clinic is reporting this adverse event only and did not request or require field service or clinical support. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[74120391]
The surgery center reported that a laser vision correction patient was presented with overcorrection. A description from the surgery center indicated the patient that had initial laser treatment performed on (b)(6) 2017. At a one month post-operative exam, the patient had sub-optical results that were overcorrections. Although, the point of refractive stability had not been reached, the surgeon made a decision to perform secondary surgery as the surgeon realized it would not stabilize. The surgery center reported that there have been no other incidents of overcorrections and believes since it was the first time using the idesign equipment; the surgeon had consulted with another surgeon who recommended the hyper focal length and optical infinity settings, although he was not comfortable changing the settings at the time, he had changed the settings. The surgeon believes changing the settings caused the overcorrections. The surgeon has reverted back to the default settings and has no issues since then. In addition, the surgery center reported 4 patients experienced overcorrections. This report is for patient #1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2017-00266 |
| MDR Report Key | 6535238 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-01 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-04-03 |
| Device Manufacturer Date | 2016-12-13 |
| Date Added to Maude | 2017-05-01 |
| 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 | 3 |
| Manufacturer Contact | MS. LOURDES GUEVARA |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478497 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | 510 COTTONWOOD DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDESIGN AWS SYSTEM |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2017-05-01 |
| Model Number | 0110-2261 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL OPTICS |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-01 |