MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-18 for TECNIS 1 MULTIFOCAL ZKB00 ZKB00U0200 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188487635]
Additional information: date of event: 12/09/2019 to 2/18/2020 if explanted, give date: not applicable as lens has not been explanted. (b)(4). Device evaluation: product testing could not be performed as the product was not returned. The reported complaint could not be verified. Manufacturing record review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. A search revealed that no similar complaints were received for this production order. 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
[188487636]
It was reported that a zkb00 20. 0 diopter intraocular lens (iol) was implanted in the patient? S left eye, and a zlb00 20. 0 was implanted in the right eye. The patient was told at the doctor? S office before the surgeries that he? D have the eyesight of a 20-year old. However, after surgery, patient is experiencing halos, blurred vision and starbursts. He? S also having difficulty while driving at night, and sign posts look twice their actual size. The patient is not using any eye drops. Thru follow-up the patient reported he had floaters prior to the implants but now the floaters are worse. He is experiencing the same symptoms in both eyes, but the left is eye worse. No further information was provided. This mdr will capture information for the left eye iol model zkb00.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00131 |
| MDR Report Key | 9849381 |
| Report Source | CONSUMER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 1 MULTIFOCAL |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | MFK |
| Date Received | 2020-03-18 |
| Model Number | ZKB00 |
| Catalog Number | ZKB00U0200 |
| 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 | 2020-03-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |