MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2017-01-13 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.
[64791242]
The clinic is reporting this adverse event only and did not request or require field service or clinical support. Manufacturing date requested but not available at the time of this report. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[64791243]
Surgeon reported that a laser vision correction patient had surgery and presented on (b)(6) 2016 with recurrent corneal erosion with surrounding brawny edema in left eye. It was reported that patient is being follow up and scheduled to be seen the next day, (b)(6). The site notified that the patient did not show for the (b)(6) appointment however was seen on (b)(6) 2017 and according to the medical record the doctor noted adverse event resolved. The resolution date is therefore (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
[66785545]
It was reported that patient had surgery on (b)(6) 2016. Manufacturing date provided 11/19/2015. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2017-00029 |
| MDR Report Key | 6250952 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2017-01-13 |
| Date of Report | 2017-02-07 |
| Date of Event | 2016-12-19 |
| Date Mfgr Received | 2017-01-13 |
| Device Manufacturer Date | 2015-11-19 |
| Date Added to Maude | 2017-01-13 |
| 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 | VALERIE SEDZICKI |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478567 |
| 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 | 2017-01-13 |
| Model Number | 0110-2261 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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. Other | 2017-01-13 |