MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for HEALON PRO TH85ML UE31742 manufactured by Johnson & Johnson Surgical Vision, Inc..
[186177212]
Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. If implanted; give date: healon pro is not an implantable device. If explanted; give date: healon pro is not an implantable device; therefore, not explanted. (b)(6). Device evaluation: no sample was returned for investigation and therefore product evaluation cannot be performed. A product deficiency is not confirmed. Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed. The product was manufactured and released according to specification.? A search revealed that no additional complaints for this order number have been received. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[186177213]
It was reported that the intraocular lens (iol) was implanted after correct set-up of the unit using healon pro as per direction for use. Doctor discovered a particle later and removed it without expanding wound or anything. As per the surgeon it is unclear if the particle came from the healon pro or the iol. No further information provided. This mdr report pertains to the suspect healon pro. A separate report will be submitted for the suspect iol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2020-00023 |
| MDR Report Key | 9892117 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-25 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | TH85ML |
| Catalog Number | UE31742 |
| 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 | 2020-03-27 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |