MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-01 for IDESIGN AWS SYSTEM 0110-0001 manufactured by Abbott Medical Optics.
[5617161]
It was reported that a laser vision correction patient presented on (b)(6) 2015 with mild superficial punctate keratitis (spk) causing moderate dryness. Date of surgery was (b)(6) 2014, 9 months prior. Patient had punctual plugs inserted in both eyes lower lids and was instructed to continue use of artificial tears, there was no surgical or additional medical intervention. It was stated that the patient had no loss of best corrected visual acuity (bcva).
Patient Sequence No: 1, Text Type: D, B5
[13042663]
The account is reporting this adverse event only and did not request or require field service or clinical support. All pertinent information available to abbott medical optics has been submitted. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2015-00098 |
| MDR Report Key | 4650477 |
| Report Source | 05 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-03-02 |
| Date of Event | 2015-02-10 |
| Date Mfgr Received | 2015-03-02 |
| Device Manufacturer Date | 2012-07-16 |
| Date Added to Maude | 2015-04-01 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 2015-04-01 |
| Model Number | 0110-0001 |
| 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. Required No Informationntervention | 2015-04-01 |