MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2017-01-03 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.
[63797145]
The clinic is reporting this adverse event only and did not request or require field service or clinical support. (b)(4). All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[63797146]
Patient had photorefractive keratectomy in both eyes 7 months ago and reported that he had several episodes where he has awoken in the morning with the sensation that his eyelids were stuck to his eyes. He reported that the experience gives him mild discomfort but is symptom free by mid morning. He presented because he said that 48 hours ago he awoke with discomfort and redness that did not improve and requested further evaluation. He was found with corneal ulcer in right eye: likely recurrent corneal erosion with secondary infection. He was also found to have a corneal infiltrate without epithelial defect and was started on hourly vigamox following an every 15 minute loading dose. Patient was seen next day and stated feeling slightly better than yesterday with mild discomfort, watering and not light sensitive. The central infiltrate is noted to be slightly larger diameter, nasally than yesterday. Patient was prescribed vancomycin every hour, doxycycline 100mg daily, bacitracin at bedtime and moxifloxacin every hour. Patient was seen on (b)(6) then again on (b)(6). Patient is getting better however not resolved. Surgeon noted in medical examination? Bland opacity; no epi defect. No brawny edema.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2017-00001 |
| MDR Report Key | 6220534 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2017-01-03 |
| Date of Report | 2017-01-03 |
| Date of Event | 2016-12-07 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2017-01-03 |
| 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 | 2017-01-03 |
| 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 | 2017-01-03 |