MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for TECNIS 1-PIECE ZCB00 ZCB0000205 manufactured by Johnson & Johnson Surgical Vision, Inc..
[185112629]
Age/date of birth: unknown/not provided. Sex/gender: unknown/not provided. If explanted, give date: not applicable as the device remains implanted. Concomitant medical products: monarch cartridges -sn: (b)(4), lot: 32633781 expiration (exp): 05/2023. Viscoat? Lot: 19j041, exp: 09/2022. Provisc? Lot: 1911oa, exp: 08/2022. (b)(6). All pertinent information available to johnson and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[185112630]
It was reported that a fiber the fiber/matter was discovered inside the eye, on the lens (model zcb00 20. 5 diopter). The fiber was removed and it was described by the doctor as being similar to silicone or plastic looking, soft and sticky. It was indicated that the lens remains implanted and there is no plan for an explant procedure. There were no surgical intervention such as vitrectomy, incision enlargement, or sutures required. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00288 |
| MDR Report Key | 9885393 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-26 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-27 |
| 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 | ZCB0000205 |
| 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 | 2020-03-26 |