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..
[188720395]
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 and no deviation related to current complaint is reported in the manufacturing record. The product was manufactured and released according to specifications. A search in complaint system revealed that one similar complaint has 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
[188720396]
It was reported that the healon 5 pro was used in two patients who experienced pressure spikes of 45 at same day postop. It was indicated that the operative eye is the right eye (od). That the intraocular pressure (iop) improved five days post-op. The patient was advised to use preservative free artificial tears and to continues taking prednisone, ofloxacin and ketorolac 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 emdr report captures patient #2. A separate emdr report is being submitted for the patient #1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2020-00022 |
| MDR Report Key | 9860973 |
| 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 |