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 2020-03-13 for TECNIS SYMFONY TORIC UNKNOWN manufactured by Johnson & Johnson Surgical Vision, Inc..
[183371866]
Date of event: unknown, not provided; best estimate is during the summer 2019. Implant date: if implanted; give date: unknown/not provided best estimate summer 2019. Explant date: if explanted; give date: n/a (not applicable). Lens remains implanted. The device was not returned as it remains implanted, therefore the product evaluation is unable to be performed. The complaint issue reported could not be verified and no product deficiency could be identified. Manufacturing records review: the manufacturing records are unable to be evaluated due to no serial number received. Historical data analysis: a search of complaints related to this production order (po) was unable to be performed due to no serial number being received. Conclusion: as a result of the investigation there is no indication of a quality product 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
[183371867]
The customer account reported that a patient who had a symfony toric intraocular lens (iol) implanted in the right (od) eye and a multifocal in the left (os) eye approximately in the summer 2019. Patient is happy with the left, but has negative dysphotopsia in the right with a darkened, blurred feeling from fixation temporally. No significant surface disease and minimal capsular opacification. The lens is rotated to 35 degrees. She is 7 months post-op and has residual astigmatism: od +1-1. 5@19. 20/25 j3; os plano 20/15 j1+. The lens could be rotated to decrease the astigmatism. There is no plan for lens exchange at this time. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00123 |
| MDR Report Key | 9827995 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-13 |
| 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 TORIC |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | POE |
| Date Received | 2020-03-13 |
| 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 | 2020-03-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |