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 2017-03-02 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.
[68750877]
(b)(4). All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[68750878]
The surgery center reported that a laser vision correction patient experienced undercorrection on the operative eye. A brief description from the surgery center indicated the patient had regressed to two diopters. The surgery center indicated it is likely the patient will require an enhancement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2017-00125 |
| MDR Report Key | 6371118 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-01 |
| Date Mfgr Received | 2017-02-07 |
| Date Added to Maude | 2017-03-02 |
| 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 | 2017-03-02 |
| 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 | 2017-03-02 |