MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-30 for TECNIS 1-PIECE ZCB00 ZCB0000185 manufactured by Johnson & Johnson Surgical Vision, Inc..
[146623533]
If explanted; give date: n/a (not applicable). Lens remains implanted. The product is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed. A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[146623534]
Patient reported that a zcb00 18. 5 diopter intraocular lens (iol) was implanted in his right (od) eye on (b)(6) 2016. At 1 day post-op, he experienced visual issues when looking at letters and people faces. They look very narrow, and the letters are merging together. When he looks at a square, it looks more like a vertical rectangle. He had mentioned this problem to his surgeon on many occasions, but no options/recommendations were provided. About a month ago, he visited his surgeon for a check up. His surgeon thinks his condition may be caused by a previous vitrectomy that was performed after cataract surgery, but prior to the lens implant. Because his eye was red his surgeon referred him to a glaucoma specialist. He was seen by the glaucoma specialist and was prescribed steroid drops. The inflammation is gone and he continues to use eye drops; however, the visual disturbance is bothering him and has impaired his daily activities including driving and reading. The patient has also saw three other doctors about his condition, and all three said that the lens was centered and it would be best not to have it removed, and the outcome may not be positive. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2019-00608 |
| MDR Report Key | 8655913 |
| Report Source | CONSUMER |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2016-04-19 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 2016-01-14 |
| Date Added to Maude | 2019-05-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TECNIS 1-PIECE |
| Generic Name | MONOFOCAL IOLS |
| Product Code | HQL |
| Date Received | 2019-05-30 |
| Model Number | ZCB00 |
| Catalog Number | ZCB0000185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-30 |