MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-04 for TECNIS SYMFONY ZXR00 ZXR00I0235 manufactured by Johnson & Johnson Surgical Vision, Inc..
[186752655]
(b)(4). If implanted; give date: unknown/not provided. If explanted; give date: not applicable as the iol remains implanted in the patient's operative eye. Initial reporter phone number: (b)(6). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[186752656]
It was reported that during post-operative examination, a patient reported of experiencing high amount of halos and glares with the intraocular lenses, model zxr00. Reportedly, the patient is also observing (ring) in periphery of right eye (od). The post-op visual acuity was reported to be ok. It was noted that the device is not available for investigation. There were no surgical interventions required and as of now doctor is not planning to perform an explant. Visual acuity pre-operative: 6/36, n/24, visual acuity post-operative: 6/9, n/8 r[s-0. 50, c-0. 50] l[s-0. 50, c-0. 50]. No additional information was provided. The patient had bilateral lens implant and this report pertains to the patient's right eye (od). A separate report is being submitted for the patient's left eye (os).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00093 |
| MDR Report Key | 9783981 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-05-22 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-04 |
| 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 | VAN SWIETENLAAN 5 |
| Manufacturer City | GRONINGEN 9728NX |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9728 NX |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TECNIS SYMFONY |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | POE |
| Date Received | 2020-03-04 |
| Model Number | ZXR00 |
| Catalog Number | ZXR00I0235 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-04 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-04 |