MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-17 for TECNIS ZMA00 ZMA00U0210 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188487393]
Age/date of birth: unknown/ not provided. Date of event: unknown, not provided. Best estimate of date of event is between 1/27/2015 and 1/13/2020. The device is not returning for evaluation per information received; therefore, a failure analysis of the complaint device cannot be completed. A review of the device/lot history record and complaint trending for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. (b)(4). Attempts have been made to obtain missing information; however, no definitive response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188487394]
It was reported that a zma00 intraocular lens (iol) was explanted from the patient's right eye (od) because patient was unhappy with the intermediate and near visual acuity. The lens was replaced with a model zkb00 iol. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00127 |
| MDR Report Key | 9840664 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-17 |
| 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 | 2020-02-18 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | MFK |
| Date Received | 2020-03-17 |
| Model Number | ZMA00 |
| Catalog Number | ZMA00U0210 |
| Device Expiration Date | 2019-09-05 |
| 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 | 2020-03-17 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |