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 2020-03-16 for TECNIS SYMFONY ZXR00 ZXR00U0175 manufactured by Johnson & Johnson Surgical Vision, Inc..
[184034511]
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019 and (b)(6) 2020. Device evaluation: product testing could not be performed because the product was not returned as it 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. As a result of the investigation, there is no indication of a product quality deficiency. Attempts have been made to obtain missing information; however, to date, no response has been received. All pertinent information available to johnson and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[184034512]
It was reported that patient was implanted with tecnis symfony lenses bilaterally on (b)(6) 2019 and (b)(6) 2019. The patient was experiencing haze and glare with lights at night and was unable to drive. Surgeon evaluated the patient and decided to exchange the lens for a regular lens. Surgeon explanted lens from patient? S right eye on (b)(6) 2020 and left eye was scheduled to be explanted on (b)(6) 2020. The visual acuity pre-op was reported as 20/30 and post op visual acuity was reported as 20/20. Reportedly tecnis symfony multifocal intraocular lens (model zxr00 +17. 5 diopter) was explanted from patient? S right eye. There was no incision enlargement, no sutures and no vitrectomy required. This report will capture information about patient? S right eye and a separate report is being submitted for patient? S left eye. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00256 |
| MDR Report Key | 9835874 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-16 |
| 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 | ROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| 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 | 2020-03-16 |
| Model Number | ZXR00 |
| Catalog Number | ZXR00U0175 |
| 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 | 2020-03-16 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-16 |