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 2020-03-09 for TECNIS SYMFONY UNKNOWN manufactured by Johnson & Johnson Surgical Vision, Inc..
[188484395]
Additional information: date of event: exact date not provided, best estimate is during 2018, about two years ago. Model: unknown, not provided. Catalog#: unknown, not provided. Expiration date: unknown, as the serial number was not provided. Serial#: unknown, information not provided. Unique identifier: udi# is unknown as the lot# was not provided. Date: unknown, information not provided. Exact date not provided, best estimate is during 2018, about two years ago. Explant date: not applicable as the lens remains implanted. Device manufactured date: unknown, as the serial number was not provided. Device evaluation: product testing could not be performed as the product was not returned. The reported complaint could not be verified. Manufacturing record review: a review of the records could not be performed as the product lot number was not provided. Conclusion: based on the investigation, no product deficiency was identified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188484396]
It was reported that a tecnis symfony intraocular lens (iol) was implanted in the patient? S operative eye. Two years post-op the patient continues to complain of halos around lights, not just at night. The refraction suggest a half a diopter of cylinder and a spherical equivalent of -. 25. She sees well 20/20 for distance and about j3 for near. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00109 |
| MDR Report Key | 9809058 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-09 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TECNIS SYMFONY |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | POE |
| Date Received | 2020-03-09 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| 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 | 2020-03-09 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |