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 2020-03-24 for TECNIS ZCT225 ZCT225U190 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188489767]
Date of event: unknown, not provided; best estimate is between (b)(6) 2020 and (b)(6) 2020. (b)(4). Device evaluation: the product was received in the replacement lens? Daisy wheel. Additionally, patient stickers and labels for the replacement lens were received. Visual inspection with the unaided eye revealed viscoelastic residue on the optic body and haptics, and that the lens was received almost cut in half, which is consistent with a lens that was handled during explant. Based on the return condition of the lens no product evaluation could be performed. The complaint issue could not be confirmed, and no product deficiency was identified. 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
[188489768]
It was reported that a zct225 19. 0 diopter intraocular lens (iol) was implanted in the patient's right (od) eye on (b)(6) 2020. It was later explanted on (b)(6) 2020 due to patient intolerance of the new lens. There was no additional surgical intervention performed during the explant process. The replacement lens is a model zcu lens. Reportedly, there was no patient injury. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00142 |
| MDR Report Key | 9876050 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Generic Name | TORIC IOLS |
| Product Code | HQL |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-03-12 |
| Model Number | ZCT225 |
| Catalog Number | ZCT225U190 |
| Device Expiration Date | 2020-03-30 |
| 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 | 2020-03-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |