MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-03-19 for TECNIS SYMFONY OPTIBLUE ZXR00V ZXR00VI215 manufactured by Johnson & Johnson Surgical Vision, Inc..
[139200326]
Date of event: unknown, not provided. If implanted; give date: n/a (not applicable). The intraocular lens was not implanted. If explanted; give date: n/a (not applicable). The intraocular lens was not implanted. Therefore, lens was not explanted. (b)(6). This report is being filed on an international product, intraocular lens (iol) model number zxr00v that has a similar product distributed in the united states, iol model no. Zxr00, which falls under pma p980040. Device evaluation: the product was returned to the manufacturing site for evaluation. The product was inspected using a microscope with a 12x magnification. It could be seen that the lens was contaminated, dust particles were present. This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area. No other anomalies were found. Manufacturing records review: the manufacturing records for the intraocular lens were reviewed. The product was manufactured and released according to specification. A search on complaints revealed that no similar complaints were received for this production order number. Labeling review: the directions for use (dfu) was reviewed. The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device. 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
[139200327]
It was reported that the inner pouch containing the intraocular lens model, zxr00v was received already open. Reportedly, the procedure was completed successfully using a back-up lens. There was no patient injury. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2019-00240 |
| MDR Report Key | 8431687 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-19 |
| Date of Report | 2019-05-13 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-04-16 |
| Device Manufacturer Date | 2017-09-13 |
| Date Added to Maude | 2019-03-19 |
| 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 | VAN SWIETENLAAN 5 |
| Manufacturer City | GRONINGEN 9728NX |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9728 NX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TECNIS SYMFONY OPTIBLUE |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | POE |
| Date Received | 2019-03-19 |
| Returned To Mfg | 2019-02-27 |
| Model Number | ZXR00V |
| Catalog Number | ZXR00VI215 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-19 |