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 2020-03-30 for TECNIS ZCT400 ZCT400U220 manufactured by Johnson & Johnson Surgical Vision, Inc..
[187441568]
Date of event: exact date unknown/not provided. Best estimate date is between (b)(6) 2019-(b)(6) 2020. (b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[187441569]
It was reported that a zct400 22. 0 diopter intraocular lens (iol) was explanted from the patient's right eye due to the patient having 2 diopters of residual cylinder. Target refraction -0. 18, post-op refraction -1. 50 2. 00 x 126, uncorrected visual acuity (ucva) 20/40, best corrected visual acuity (bcva) 20/25, lens location eight degrees. Through follow-up, it was learned that the lens was replaced with a different model lens zcu300 with a 22. 0 diopter. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00296 |
| MDR Report Key | 9900511 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Generic Name | TORIC IOLS |
| Product Code | HQL |
| Date Received | 2020-03-30 |
| Model Number | ZCT400 |
| Catalog Number | ZCT400U220 |
| 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 | 2020-03-30 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |