MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-27 for TECNIS ZCV150 ZCV1500195 manufactured by Johnson & Johnson Surgical Vision, Inc..
[187441076]
Age/date of birth: unknown/not provided. If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery. If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery. Phone number: (b)(6). This report is being filed on an international device; tecnis? Toric iol, model zcv150 that has a similar device, zct which is distributed in the united states under pma p980040. (b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[187441077]
A surgeon reported that during cataract surgery, the procedure was completed successfully until they moved to the iol implantation process. At that point, the posterior capsule was ruptured due to the edge part of the lead haptic or optic contacting the posterior capsule when the intraocular lens (model zcv150 19. 5) was being implanted. After the posterior capsule was damaged, the intraocular lens (iol) was cut into three (3) parts with a lens cutter and in the process, the iol touched the iris which resulted in iris bleeding. There was no vitrectomy performed, but the anterior chamber was washed and the procedure was completed with a competitor? S product that was fixed in the bag. Reportedly, the patient was referred to a university hospital because his visual acuity did not recover. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00293 |
| MDR Report Key | 9887330 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-27 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Generic Name | TORIC IOLS |
| Product Code | HQL |
| Date Received | 2020-03-27 |
| Model Number | ZCV150 |
| Catalog Number | ZCV1500195 |
| 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 | 2020-03-27 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |