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 2016-07-01 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.
[48712371]
(b)(4). Field service specialist (fss) was unable to verify either issue nor isolate a probable cause after checking equipment and troubleshooting. Opened head and observed surfaces are clear of dust and other particles. Hss spot retention prior to optic cleaning is 1437 of 1444 spots and after cleaning is 1431 of 1450 spots for a percentage ratio of less than 1. 5 percent in both cases. Target evaluation was performed and found system within specifications. Observed that target shuts off when privacy screen becomes active but will return when privacy screen ends. Loosened adjustment set screw to provide smoother operation of head in side to side action. Observed lane length set at 20 ft. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[48712372]
Account reported having patient with overcorrection and problems with accommodation. Patient had original surgery on (b)(6) 2016 best corrected visual acuity (bcva) 20/20+ in both eyes. Microstriae was reported on left eye on (b)(6) 2016 and flap lift and smooth in left eye was performed next day. On (b)(6) 2016 bcva in both eyes is 20/20, patient is waiting to have enhancement procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2016-00665 |
| MDR Report Key | 5767051 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-01 |
| Date of Report | 2016-07-01 |
| Date of Event | 2016-01-28 |
| Date Mfgr Received | 2016-06-02 |
| Device Manufacturer Date | 2015-12-03 |
| Date Added to Maude | 2016-07-01 |
| 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 | 2016-07-01 |
| 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 | 2016-07-01 |