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 2020-03-20 for TECNIS SYMFONY TORIC ZXT150 ZXT150U240 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188488886]
(b)(4). Device evaluation: the device was received wrapped in paper at the manufacturing site for evaluation. Visual inspection with the unaided eye revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant. Additionally, viscoelastic residue was observed on the optic body and haptics. Based on the condition of the return lens no product evaluation could be performed. The complaint issue could not be confirmed, and no product deficiency was identified. Manufacturing record review: the manufacturing process record was evaluated and no deviation and/or nonconformance were 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
[188488887]
It was reported that the intraocular lens (model zxt150 24. 0 diopter) was explanted from patient? S right eye (od) in secondary surgical procedure due to myopic miss. A replacement lens of the same model, but different diopter (22. 0) was used. The patient is doing fine post-operation and no patient injury was reported. There were no other surgical or medical interventions required. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00135 |
| MDR Report Key | 9858695 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-06 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Returned To Mfg | 2020-03-05 |
| Model Number | ZXT150 |
| Catalog Number | ZXT150U240 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |