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 2020-03-11 for TECNIS SYMFONY TORIC ZXT150 ZXT150U165 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188391412]
Date of event: not provided, best estimate date is between (b)(6) 2019 - (b)(6) 2020. (b)(4). Device evaluation: the lens was received in a specimen cup submerged in an unknown liquid. Visual inspection with the unaided eye revealed that the lens was received cut at the base of one haptic (no haptic received), which is consistent with a lens that was handled during explant. Additionally, a second haptic was observed to be detached (no haptic received). No cosmetic defects were observed on the optic body. Based on the condition of the return lens, no further product evaluation could be performed (visual inspection of haptics). The complaint issue could not be confirmed, and no product deficiency was identified. Manufacturing records review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specification. A search revealed that no other complaints have been received for this production order. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188391413]
It was reported that a symfony intraocular lens (iol) was explanted from patient's right eye due to the patient experiencing halo and glare. The replacement lens is a three piece non-johnson & johnson iol. The patient is reported to be doing well post-exchange. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00115 |
| MDR Report Key | 9815710 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-10 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| Returned To Mfg | 2020-02-28 |
| Model Number | ZXT150 |
| Catalog Number | ZXT150U165 |
| 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 | 2020-03-11 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |