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 2020-03-20 for TECNIS 1 MULTIFOCAL ZLB00 ZLB00U0180 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188488992]
(b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188488993]
It was initially reported that a tecnis multifocal intraocular lens (iol) was implanted into the patient? S left eye. The patient was unable to tolerate it. Both distance and near vision at one month was 20/70. The patient is monocular, so this wasn? T something she was able to try to wait out. The iol was explanted lens was replaced with a non-johnson & johnson monofocal lens. Additional information states vision progressively worsened over one month to 20/70 best corrected visual acuity (bcva) at near and distance. One-month post explant/exchange the patient is happy with 20/20 uncorrected at distance and 20/20 at near with correction. It was also noted, in order to explant the multifocal lens, the patient returned to the operating room (or) where the main wound was reopened and enlarged, the former lens was cut out using the pac-man technique, and the new monofocal lens was implanted. No patient injury was reported. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00134 |
| MDR Report Key | 9861022 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-04 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-20 |
| 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 | ROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| 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 | 2020-03-20 |
| Model Number | ZLB00 |
| Catalog Number | ZLB00U0180 |
| 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 | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |