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 2020-01-03 for HEALON GV manufactured by Johnson & Johnson Surgical Vision, Inc..
[183315138]
Patient age/date of birth: unknown as information was not provided. Date of event: exact date not provided, best estimate (b)(6) 2019. Lot number: unknown as information was not provided. Expiration date: unknown as product lot number was not provided. Udi number: udi # is unknown as product lot number was not provided. If implanted, give date: not applicable, as healon gv is not an implantable device. If explanted, give date: not applicable, as healon gv is not an implantable device. Device manufacture date (mm/dd/yyyy): unknown, as product lot number was not provided. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[183315139]
It was reported patient was injected with healon gv, lot number unknown, in the ocular dexter (right eye) on (b)(6) 2019. On (b)(6) 2019 the entire anterior chamber (ac) looks like it has suspended pigment cells. The patient presented after glaucoma surgery with a flattened chamber; the chamber was reformed with healon gv and got intraocular pressure (iop) up to 17mmhg. Subsequent to that, the patient returned to office with very high intraocular pressure (as high as 57), and signs that there is still much gv in the ac. Range of pressure in patient? S od prior to (b)(6) was 24mmhg to 36mmhg. On (b)(6) 2019 iop 13. On (b)(6) 2019 iop 36. On (b)(6) 2019 iop 50. On (b)(6) 2019 56 and they tapped the incision to lower. On (b)(6) 2019 iop 8 and os was similar. The patient? S vision in both eyes is hand motion. No additional information was provided to johnson & johnson surgical vision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2020-00002 |
| MDR Report Key | 9549344 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-03 |
| Date of Report | 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 | 2020-02-03 |
| Date Added to Maude | 2020-01-03 |
| 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 | RAPSGATAN |
| Manufacturer City | UPPSALA 751 82 |
| Manufacturer Country | SE |
| Manufacturer Postal Code | 751 82 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEALON GV |
| Generic Name | OVDS |
| Product Code | LZP |
| Date Received | 2020-01-03 |
| Model Number | HEALON GV |
| Catalog Number | HEALON GV |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-03 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-03 |