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 2020-03-12 for IDESIGN AWS SYSTEM 0110-3450 manufactured by Johnson & Johnson Surgical Vision, Inc..
[183162118]
The device manufacture date was not available at the time of this report. ((b)(4). The system was evaluated by a field service engineer. The field service found no issues with the unit. A field service checklist was performed. The unit complied with all factory settings. A review of records related to the device including labeling, complaint trending, and risk documentation will be performed. Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[183162119]
It was reported that a laser vision correction patient had surgery on (b)(6) 2020 which resulted in 2 diopters of induced astigmatism in the right eye. The patient was iol implant. The case was photorefractive keratectomy (prk) utilizing amoils brush to remove epithelium. Pre op manifest: -2. 50 +4. 25 x 100. This report is for the idesign. A separate report will be filed for the excimer laser.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00175 |
| MDR Report Key | 9824738 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-30 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-12 |
| 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 | SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | 510 COTTONWOOD DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDESIGN AWS SYSTEM |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2020-03-12 |
| Model Number | 0110-3450 |
| Catalog Number | 0110-3450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Product Code | --- |
| Date Received | 2020-03-12 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-12 |