MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for TECNIS ITEC PRELOADED 1-PIECE IOL PCB00 PCB0000250 manufactured by Johnson & Johnson Surgical Vision, Inc..
[184996523]
Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. If explanted, give date: not applicable, remains implanted in the eye. (b)(6). Device evaluation: sample is not available as it was discarded, the complaint issue reported, product deficiency could not be determined. Manufacturing records review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specification. A search revealed one additional complaint folder for this production order number device advancement issue. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[184996524]
It was reported that during implantation there was observed a small kind of thread on top of the optic of the intraocular lens. The piece of thread looked a bit brassy, and it was removed from the eye successfully, and there was no patient injury. Everything was reported as discarded. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00283 |
| MDR Report Key | 9881813 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-25 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-26 |
| 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 ITEC PRELOADED 1-PIECE IOL |
| Generic Name | MONOFOCAL IOLS |
| Product Code | HQL |
| Date Received | 2020-03-26 |
| Model Number | PCB00 |
| Catalog Number | PCB0000250 |
| 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 | 2020-03-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |