MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-05 for TECNIS SYMFONY ZXR00 ZXR00U0190 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188421464]
(b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188804396]
Date of event: unknown, information not provided. If explanted, give date: not applicable, lens has not been explanted. The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed. A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. Note: the device was manufactured at the kulim site which has been closed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188804397]
It was reported that a patient has bilateral zxr00 intraocular lenses (iol) implanted. However, the patient is experiencing circles and glare in the form of a huge starburst at night, which has limited the patient from driving at nighttime. The symptoms are almost identical in each eye. Both lenses are still implanted. Patient has seen his eye doctor multiple times and was using eye drops. Per the patient, nothing has worked to better his night vision. Patient states day vision is perfect but is considering a second opinion to address night vision. No further information was provided. This report captures the event for the left eye. A separate report is being submitted for the right eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020664-2020-00018 |
| MDR Report Key | 9795570 |
| Report Source | CONSUMER |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-20 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-08 |
| Date Added to Maude | 2020-03-05 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | LOT H.S (D) 70252, PT 2489 JALAN HI TECH 11, INDUSTRIAL Z |
| Manufacturer City | KULIM HI TECH PARK 09000 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 09000 |
| 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 | 2020-03-05 |
| Model Number | ZXR00 |
| Catalog Number | ZXR00U0190 |
| 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 | 2020-03-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-05 |