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 2020-03-12 for TECNIS SYMFONY TORIC ZXT150 ZXT150U190 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188486391]
Additional information: if explanted, give date: not applicable, the lens remains implanted. Device evaluation: product testing could not be performed as the product was not returned. The reported complaint could not be verified. Manufacturing record review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. A search revealed that no similar complaints were received for this production order. 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
[188486392]
It was initially reported that a zxt150 19. 0 diopter intraocular lens (iol) rotated. At one day post-op the iol was at 156 degrees. The patient was seen again (b)(6) 2019 and reported blurry vision. The reported issue was noted to significantly affect the patient? S daily activities as the patient was unable to see clearly, and as a librarian, she needs to be able to see. The patient was brought back in (b)(6) 2019, the iol in the left eye was rotated 34 degrees clockwise and remains implanted. There were no patient injuries. Reportedly, the patient? S vision is great now and they are very happy. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00118 |
| MDR Report Key | 9822412 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-04 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-13 |
| 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 TORIC |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | POE |
| Date Received | 2020-03-12 |
| Model Number | ZXT150 |
| Catalog Number | ZXT150U190 |
| 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 |