MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-06-26 for IDESIGN AWS SYSTEM 0110-0001 manufactured by Abbott Medical Optics.
[3472502]
The clinic reported that a laser vision correction patient presented at a post op exam with an over corrected vision treatment in each eye. The patient's best corrected visual acuity was 6/9 (20/30) in each eye.
Patient Sequence No: 1, Text Type: D, B5
[10864099]
(b)(4): undercorrected vision. Device currently not marketed in the us. An amo authorized representative evaluated the system at the customer location and found that the customer had changed the lane length of the manifest refraction device (mr) but did not update the lane length in the idesign to correspond with the change. Field service corrected the settings in the idesign to match the mr. Instructions were provided to the customer by the amo clinical development manager stressing the importance of following the protocol for matching the mr with idesign scan and to use the recommended nomogram. All pertinent information available to amo has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2013-00232 |
| MDR Report Key | 3191457 |
| Report Source | 01,05,07 |
| Date Received | 2013-06-26 |
| Date of Report | 2013-06-08 |
| Date of Event | 2013-03-22 |
| Date Mfgr Received | 2013-06-08 |
| Device Manufacturer Date | 2012-10-08 |
| Date Added to Maude | 2013-06-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAROL KAIL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478598 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | AMO MANUFACTURING 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 | 2013-06-26 |
| Model Number | 0110-0001 |
| Catalog Number | 0110-0001 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-06-26 |