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 2017-04-14 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.
[72877086]
Concomitant product(s): - field service specialist visited the account and cleaned optics of balanced salt solution, which was causing an artifact. Adjusted flat to plano and adjusted the sphere. Tested system. No problems found all pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[72877087]
It was reported that patient had lasik with idesign procedure and presented with overcorrection in right eye post treatment. Patient experienced loss of best corrected visual acuity (bcva) equal to or above 2 lines. No intervention was required. Right eye: pre-op: -6. 86 -0. 35 x 41 bcva 20/20, post-op: +1. 75 -0. 25 x 95 bcva 20/30.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2017-00230 |
| MDR Report Key | 6495673 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-14 |
| Date of Event | 2017-03-10 |
| Date Mfgr Received | 2017-03-20 |
| Device Manufacturer Date | 2016-08-25 |
| Date Added to Maude | 2017-04-14 |
| 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 | 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 | 2017-04-14 |
| 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. Other | 2017-04-14 |