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 2020-03-09 for TECNIS SYMFONY TORIC ZXT150 ZXT150U220 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188389726]
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019 and (b)(6) 2020. (b)(4). All pertinent information available to johnson and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188389727]
It was reported that tecnis symfony toric multifocal intraocular lens (model zxt150 +22. 0 diopter) was explanted from patient? S left eye because of patient experiencing myopia. At explant there was no incision enlargement, no vitrectomy and no sutures required. No patient injury reported. Reportedly the replacement lens was the same model, but lower diopter (+21. 5). The patient is doing well post-exchange. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00108 |
| MDR Report Key | 9804138 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-19 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-09 |
| 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 TORIC |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | POE |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-02-28 |
| Model Number | ZXT150 |
| Catalog Number | ZXT150U220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-09 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |