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 2020-03-12 for TECNIS SYMFONY ZXR00 ZXR00U0230 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188486131]
Date of event: unknown, not provided, but the best estimate is between 8/15/2018 and 10/31/19. (b)(4). Device evaluation: product testing could not be performed because the product was discarded. The reported complaint was not confirmed. Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported. The search revealed that no other complaints have been received for this production order number. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. All pertinent information available to johnson and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188486132]
It was reported that tecnis symfony multifocal intraocular lens (model zxr00 +23. 0 diopter) was explanted from patient? S left (os) eye because of patient experiencing blurry/waxy vision. Reportedly a lens from another manufacturer with same diopter was used as replacement for the patient. Incision enlargement was performed and sutures were required during the procedure. Visual acuity pre-op was 20/20. The device has been discarded. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00120 |
| MDR Report Key | 9824239 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-18 |
| 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 | 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 | 2020-03-12 |
| Model Number | ZXR00 |
| Catalog Number | ZXR00U0230 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2020-03-12 |