MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-17 for TECNIS SYMFONY ZXR00 ZXR00U0165 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188487032]
Date of event: exact date unknown/not provided. Best estimate date is between 11/15/19-2/10/19. (b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188487033]
It was reported that a post-lasik patient ended up two diopters hyperopic post-implant of a model zxr00 intraocular lens (iol) in the left eye. Therefore, the lens was explanted. There were no sutures or vitrectomy required. The patient is reported as doing okay. No additional information was provided to johnson & johnson surgical vision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00125 |
| MDR Report Key | 9839348 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-31 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-17 |
| 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 | MFK |
| Date Received | 2020-03-17 |
| Model Number | ZXR00 |
| Catalog Number | ZXR00U0165 |
| 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 | 2020-03-17 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |