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 2019-12-23 for HEALON PRO HEALON PRO 0,85 ML CE CENTRAL 10270012 manufactured by Johnson & Johnson Surgical Vision, Inc..
[188716860]
Age/date of birth: unknown/ not provided. Sex/gender: unknown/ not provided. (b)(6). If implanted; give date: the viscoelastic, healon pro is not an implantable device. If explanted; give date: the viscoelastic, healon pro is not an implantable device. Therefore, not explanted. Additional concomitant product - healon gv pro lot# ue31467. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188716861]
It was reported that after preparation during a cataract surgery, surgeon discovered a little blue string, which was removed with irrigation and aspiration. Reportedly that the foreign material came from the viscoelastic (ovd) healon pro. No patient injury reported. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2019-00113 |
| MDR Report Key | 9513559 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-23 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-11-26 |
| 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 | 2019-12-23 |
| 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 | 2019-12-23 |
| Returned To Mfg | 2020-01-14 |
| Model Number | HEALON PRO 0,85 ML CE CENTRAL |
| Catalog Number | 10270012 |
| Lot Number | UE31547 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-12-23 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-23 |