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 2017-10-12 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.
[89343510]
Manufacturing date - not available at the time of this report. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[89343511]
It was reported that presented for the 3 month post op visit on (b)(6) 2017 with mild haze in both eyes. The haze was above and below the visual axes. At the 6 months post op visit on (b)(4) 2017 the haze appeared more dense but was still located only above and below the visual axix and was again not considered to be visually significant as uncorrected visual acuity was 20/16 in right eye and 2016 in left eye (20/13 both eyes). At that visit, the subject was treated with fml every 2 hours for 2 weeks. The subject was seen on the (b)(6) and placed on a 6 week fml taper on that last visit. Subject was scheduled for (b)(6) 2017 but did not attend. This report is for the idesign system. A separate report is being submitted for the visx system.
Patient Sequence No: 1, Text Type: D, B5
[112894927]
A record review was performed. A product deficiency review was performed and there is no product deficiency identified. A document, service history, and trending was reviewed. There is not a recognizable adverse trend. The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation. A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2017-00889 |
| MDR Report Key | 6947055 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-12 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-08-09 |
| Date Mfgr Received | 2017-11-06 |
| Date Added to Maude | 2017-10-12 |
| 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 | 2017-10-12 |
| Model Number | 0110-2261 |
| Catalog Number | 0110-2261 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| 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. Required No Informationntervention | 2017-10-12 |