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 2020-03-20 for HEALON 5 PRO TV60ML 10240015 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188720936]
Additional information: gender/sex: unknown, information not provided. Date of event: unknown, information 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 evaluation: product testing could not be performed as the product was not returned. The reported complaint could not be verified. Manufacturing record review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. A search revealed that no complaints have previously been reported on this batch. Conclusion: as a result of the investigation there is no indication of a product quality 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
[188720937]
It was reported that the customer used healon 5 pro in two patients that experienced pressure spikes of 45 at same day postop. Thru follow-up it was reported that the operative eye is the right eye. Patient was taking daimox but discontinued taking it as the pressure improved five days post-op. Patient continues to take prednisone and ketorolac and ofloxain twice a day. Customer also reported that the patient is doing fine as the pressure went down post-op. No further information is available. This report captures patient #1. A separate medwatch is being submitted for patient #2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2020-00021 |
| MDR Report Key | 9858668 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-20 |
| 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 5 PRO |
| Generic Name | OVDS |
| Product Code | LZP |
| Date Received | 2020-03-20 |
| Model Number | TV60ML |
| Catalog Number | 10240015 |
| Lot Number | UE31141 |
| 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 | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |