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 2020-03-31 for TECNIS 1-PIECE ZCB00 ZCB0000305 manufactured by Johnson & Johnson Surgical Vision, Inc..
[187706159]
(b)(4). If implanted, if explanted, give date: not applicable as lens was removed/replaced within the same surgery. Device evaluation: the original folding carton and directions for use were received. Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics. The lens was received cut in half, which is consistent with a lens that was handled during explant. 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. The complaint search found 1 report but it's not related to the reported event. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[187706160]
It was reported that a zcb00 iol 30. 5 diopter was inserted into the patient? S operative eye. After insertion the doctor noticed a tear in the lens. The iol was removed and replaced during the same procedure with the same model. The incision was enlarged. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00304 |
| MDR Report Key | 9908582 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| 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 | 2020-03-04 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Returned To Mfg | 2020-03-25 |
| Model Number | ZCB00 |
| Catalog Number | ZCB0000305 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |