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 2020-03-05 for TECNIS 1 MULTIFOCAL ZMB00 ZMB00U0205 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188270327]
Date of event: unknown, not provided; best estimate is between (b)(6) 2019 and (b)(6) 2020. (b)(4). Device available for evaluation: yes. Returned to manufacturer on: 2/24/2020. Device returned to manufacturer: yes. Device evaluation: the product was received in the replacement lens? Daisy wheel along with a completed complaint intake form. Visual inspection with the unaided eye revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant. Additionally, viscoelastic residue was observed on the optic body and haptics. Based on the condition of the return lens no product evaluation could be performed. No product deficiency was identified. The complaint issue reported was not verified. Manufacturing records review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specification. Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number. 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
[188270328]
It was reported that a zmb00 intraocular lens (iol) was implanted in the patient's left (os) eye on (b)(6) 2019. It was later explanted on (b)(6) 2020 due to diplopia anisometropia issues and replaced with a model zxr00 iol. An incision enlargement was required for the explant, and no patient outcome was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00103 |
| MDR Report Key | 9791199 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-04 |
| 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 | 2020-02-24 |
| Model Number | ZMB00 |
| Catalog Number | ZMB00U0205 |
| 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 |