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 2020-03-26 for TECNIS 1-PIECE ZCB00 ZCB0000175 manufactured by Johnson & Johnson Surgical Vision, Inc..
[187439078]
If implanted, give date: not applicable, the lens was removed/replaced within the initial procedure. If explanted, give date: not applicable, the lens was removed/replaced within the initial procedure. (b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[187439079]
It was reported that a zcb00 intraocular lens (iol) was removed from the patient's right (od) eye upon insertion when the surgeon noticed a scratch on the lens. Incision was enlarged along with one suture used during the procedure. The current patient status was reported as doing good. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00291 |
| MDR Report Key | 9886607 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-25 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-26 |
| 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 1-PIECE |
| Generic Name | MONOFOCAL IOLS |
| Product Code | HQL |
| Date Received | 2020-03-26 |
| Model Number | ZCB00 |
| Catalog Number | ZCB0000175 |
| 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 | 2020-03-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |