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 2020-03-03 for TECNIS SYMFONY ZXR00 ZXR00U0155 manufactured by Johnson & Johnson Surgical Vision, Inc..
[186751894]
Date of event: unknown, not provided, best estimate is between (b)(6) 2019 and (b)(6) 2020. (b)(4). Device evaluation: the product testing could not be performed as the product was not returned (the lens was discarded by the account). The reported complaint cannot be confirmed. Manufacturing records review: the manufacturing records for the device were reviewed. The product was manufactured and released according to specification. A search in complaint history revealed no similar complaints were received for this production order number. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[186751895]
It was reported that an intraocular lens (iol), model zxr00 15. 5 diopter was explanted from a female patient's right eye due to sphere halos and something to do with readers which the patient felt like she was looking through cotton candy. It was indicated that the lens was implanted at another location on (b)(6) 2019. A non johnson & johnson lens of 15. 0 diopter was used as replacement. There were no incision enlargement, vitrectomy or sutures required. Reportedly, the patient is doing well post-op and no patient injury was reported. It was noted that the product will not be returned as it was thrown away. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00091 |
| MDR Report Key | 9778769 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-03-03 |
| 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 | 2020-03-03 |
| Model Number | ZXR00 |
| Catalog Number | ZXR00U0155 |
| 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 | 2020-03-03 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |