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 2020-03-12 for TECNIS 1 MULTIFOCAL ZLB00 ZLB00U0100 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188805030]
Date of event: unknown as information was not provided. The best estimate date is between (b)(6) 2020 - (b)(6) 2020. (b)(4). Attempts were made to contact the customer account requesting additional information however, to date no response has been received. Note: the device was manufactured at the (b)(4) site which has been closed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188805031]
It was reported zlb00 10. 0 diopter intraocular lens (iol) was implanted in the patient? S ocular sinister (left eye) on (b)(6) 2020. The lens was explanted on (b)(6)2020 due to complaint of mechanical failure. It was reported the incision was enlarged and vitrectomy was performed however there was no patient injury and suture(s) were not required. The lens was removed in one piece. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020664-2020-00021 |
| MDR Report Key | 9827625 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-12 |
| 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 | 2020-02-13 |
| Date Added to Maude | 2020-03-12 |
| 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 | LOT H.S (D) 70252, PT 2489 JALAN HI TECH 11, INDUSTRIAL Z |
| Manufacturer City | KULIM HI TECH PARK 09000 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 09000 |
| 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 | 2020-03-12 |
| Model Number | ZLB00 |
| Catalog Number | ZLB00U0100 |
| 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 | 2020-03-12 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |