MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-06 for HEALON PRO TH85ML 10260012 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188717462]
Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. Date of event: unknown, 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 implantable device. Initial reporter name: unknown, not provided. (b)(6). Device evaluation: the product testing could not be performed as the product was not returned for evaluation. The reported complaint cannot be confirmed. Manufacturing records review: a manufacturing record review was performed and no deviation is reported in the manufacturing record. A search in the complaint system revealed no 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
[188717523]
It was reported that foreign substances were collected during the procedure. The account suspects the healon product and /or the phaco tubing pack. The procedure was completed successfully with a back up and there was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2020-00005 |
| MDR Report Key | 9679839 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-06 |
| 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 PRO |
| Generic Name | OVDS |
| Product Code | LZP |
| Date Received | 2020-02-06 |
| Model Number | TH85ML |
| Catalog Number | 10260012 |
| Lot Number | UE31603 |
| 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 | 2020-02-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |