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 2017-01-17 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.
[65024807]
The clinic is reporting this adverse event only and did not request or require field service or clinical support. Manufacturing date oct/2015 all pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[65024808]
It was reported that patient had surgery on (b)(6) 2016 and presented on (b)(6) 2016 with clinically significant corneal haze in both eyes (more in left than in right side) and loss of 2 lines best spectacle corrected visual acuity in left eye. Patient was prescribed predforte 1% for both eyes every 2 hours and refresh tears every 2 hours. Patient was told to return for follow up in 10 days. Follow up occurred on (b)(6) 2016 with medical finding of mild corneal haze and reticular pattern opacification within ablation zone, somewhat less dense. Per examining doctor, responding well to the treatment. Patient to continue predforte and uv protection. Patient was told to return for follow up in 10 days.
Patient Sequence No: 1, Text Type: D, B5
[69459802]
In the initial mdr only the month and year of manufacture was provided. The complete manufacturing date has now been provided. 10/09/2015. Additional information: account reported that patient's right eye mild haze is not affecting refraction, the left eye moderate haze refraction was possible. Also the relatively clear zones/ patches between reticular pattern opacification appear increasingly clear in both eyes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2017-00036 |
| MDR Report Key | 6258924 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2017-01-17 |
| Date of Report | 2017-03-08 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2017-02-10 |
| Device Manufacturer Date | 2015-10-09 |
| Date Added to Maude | 2017-01-17 |
| 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 | 2017-01-17 |
| Model Number | 0110-2261 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-01-17 |