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 2016-08-31 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.
[53661406]
(b)(4). Applications support specialist verified the calibration of the idesign and looked at the fixation target and verified it. Everything was within specifications and the fixation target looked good. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[53661407]
Surgeon reported patient had original procedure on (b)(6) 2015. Patient post op was: one month: right 3. 25 -0. 50 61 uncorrected 20/20; left 3. 00 -0. 50 14 uncorrected 20/25. Three months: right 3. 50 -0. 75 95 best corrected 20/15; left 3. 75 -0. 75 120 best corrected 20/15. Surgeon did enhancement at 3 months. Prescription 3 months post enhancement: right uncorrected 20/20. Left 2. 25 -1. 50 x 20 uncorrected is 20/30 and best corrected is 20/30+.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2016-00810 |
| MDR Report Key | 5919546 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-31 |
| Date of Event | 2015-12-30 |
| Date Mfgr Received | 2016-08-04 |
| Device Manufacturer Date | 2015-12-17 |
| Date Added to Maude | 2016-08-31 |
| 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 | MRS. 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 | 2016-08-31 |
| Model Number | 0110-2261 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-08-31 |