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 2020-03-05 for TECNIS 1 MULTIFOCAL ZLB00 ZLB00U0195 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188269831]
Additional information: (b)(4). Device evaluation: the product was returned to the manufacturing site for evaluation. The lens was received in a petri dish along with hard copy emails and complaint intake forms. Visual inspection with the unaided eye revealed viscoelastic residue on the optic body and haptics. After cleaning the lens and performing a visual inspection under magnification, no cosmetic defects could be observed. No complaint issue could be confirmed, and no product deficiency was identified. 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 other 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
[188269832]
It was reported that a zlb00 intraocular lens (iol) 19. 5 diopter was explanted from the patient? S left eye. Pre visual acuity was 20/70+, post visual acuity is 20/30. The patient was not happy, and was experiencing fuzzy, milky vision. The patient also experienced blurry vision both distance and near. The iol was explanted and replaced with a non j&j lens. There was no capsule tear, vitrectomy or sutures required, but the incision was enlarged. The patient is doing well post exchange. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00104 |
| MDR Report Key | 9791244 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-20 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-05 |
| 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 1 MULTIFOCAL |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | MFK |
| Date Received | 2020-03-05 |
| Returned To Mfg | 2020-02-21 |
| Model Number | ZLB00 |
| Catalog Number | ZLB00U0195 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-05 |