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 2016-10-20 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.
[58016483]
(b)(4). Field service specialist (fss) visited the account and found no problems with the system as it met abbott? S specifications. As a proactive measure fss replaced the aberrometer and transferred customers database over to the new computer and gave the customer the hard drives out of other computer. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[58016484]
The clinic reported that a laser vision correction patient had photorefractive keratectomy surgery on (b)(6) 2015 and presented at the 6 months post treatment visit with overcorrection in right eye. It was stated that the patient had no loss of best corrected visual acuity (bcva). Patient manifest refraction at the 6 months follow up visit for right eye was 2. 25 x 0. 75 x 125.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2016-00886 |
| MDR Report Key | 6045926 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-20 |
| Date of Event | 2015-12-03 |
| Date Mfgr Received | 2016-09-24 |
| Date Added to Maude | 2016-10-20 |
| 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 | 2016-10-20 |
| 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. Other | 2016-10-20 |