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 2020-03-26 for TECNIS 1-PIECE ZCB00 ZCB0000205 manufactured by Johnson & Johnson Surgical Vision, Inc..
[184997691]
Additional information: if explanted; give date: not applicable as the iol remains implanted in the patient's eye. Device evaluation: product testing could not be performed because the product was not returned as the iol remains implanted in the patient's eye. A product quality deficiency could not be confirmed. The reported issue was not verified. Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification. Historical data analysis: a search revealed that no other complaints for this production order number have been received. Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency. The reported issue was not verified. Attempts were made to contact the customer account requesting additional 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
[184997692]
It was reported zcb00 20. 5 diopter intraocular lens (iol) was implanted in the patient? S operative eye and there was a film stuck on the posterior side of the optic. The doctor was able to remove the film by going underneath the lens and using the irrigation/aspiration (i/a) handpiece. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00285 |
| MDR Report Key | 9881825 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-25 |
| 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 | 2020-02-26 |
| 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 |