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 2020-03-25 for TECNIS 1-PIECE ZCB00 ZCB0000050 manufactured by Johnson & Johnson Surgical Vision, Inc..
[186567212]
If explanted, give date: unknown/not provided. (b)(4). Device evaluation: the lens was received wrapped in paper at the manufacturing site for evaluation. Visual inspection with the unaided eye revealed viscoelastic residue on the optic body and haptic, and that the lens was received cut in pieces (with pieces of the lens and a haptic missing), which is consistent with a lens that was handled during explant. Additionally, fibers were observed on the lens, which can be attributed to receiving the lens wrapped in paper. Based on the return condition of the lens no product evaluation could be performed. The complaint issue could not be confirmed, and no product deficiency was identified. Manufacturing record review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. A search in complaint system revealed that no other complaints have been received for this production order. Conclusion: 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 & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[186567213]
It was reported that the intraocular lens (model zcb00 5. 0 diopter) was explanted from patient? S right eye (od) in secondary surgical procedure as the patient wanted something different. Lens from another manufacturer was used as the replacement lens. No surgical and/or medical interventions such as incision enlargement, vitrectomy, or sutures were reported. There was no patient injury reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00275 |
| MDR Report Key | 9879911 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-18 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | ZCB00 |
| Catalog Number | ZCB0000050 |
| 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 | 2020-03-25 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |