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 2020-03-19 for EMERALD EMERALDC30 manufactured by Johnson & Johnson Surgical Vision, Inc..
[184051808]
Additional information: age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. Lot#: unknown, information not provided. Unique identifier: a complete udi# is unknown as the lot# was not provided. Expiration date: unknown, as lot number was not provided. If implanted, give date: not applicable as this is not an implantable device. If explanted, give date: not applicable as this is not an explantable device. Device manufacture date: unknown, as lot number not provided. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[184051809]
It was reported that a model ar40 intraocular lens (iol) of an unknown diopter was inserted into the patient? S eye. But a white, gummy material was noticed on the iol after insertion, but prior to the lens being injected. Reportedly, the white, gummy material is inert and causes no problems. The patient looks and sees fine. No further information was provide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00265 |
| MDR Report Key | 9851675 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-07 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-22 |
| Date Added to Maude | 2020-03-19 |
| 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 | EMERALD |
| Generic Name | SURGICAL ADJUNCTS |
| Product Code | KYB |
| Date Received | 2020-03-19 |
| Model Number | EMERALDC30 |
| Catalog Number | EMERALDC30 |
| Lot Number | UNKNOWN |
| 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 | 2020-03-19 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |