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 2020-03-03 for HEALON GV PRO TG85ML 10270514 manufactured by Johnson & Johnson Surgical Vision, Inc..
[181813697]
If implanted; give date: the healon gv pro is not an implantable device. If explanted; give date: the healon gv pro is not an implantable device; therefore, not explanted (b)(6). This complaint is part of the recall - report number 2020664-12/02/19-001-r: johnson & johnson surgical vision (jjsv) issued a voluntary recall on november 22, 2019. It has been reported customers have described healon gv pro as behaving differently than the legacy healon gv, especially in regard to the techniques required to remove the product from the eye. An increase of intra-ocular pressure (iop) is reported if there are small amounts of healon gv pro remaining behind the operative eye. This voluntary recall is being initiated due to received reports of healon gv pro being difficult to remove from the eye, leading to increased post-operative iop requiring additional intervention. Potential clogging of phacoemulsification equipment tubing has also been reported, which may lead to delay in the procedure or ocular injury. There are twenty-one affected lot numbers. The recall notification letter has been sent to all customers instructing them to return the units of healon gv pro from the twenty-one (21) affected lots. Johnson & johnson surgical vision has initiated a corrective and preventative actions (capa) to investigate and address the issue. Action items generated from the capa will be submitted in the future interim report(s) as part of the recall process. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[181813698]
It was reported post cataract surgery, a patient suffered severe ocular hypertensive crisis, with a campimetric alteration. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2020-00012 |
| MDR Report Key | 9781314 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| 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 | 2020-03-03 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 0 |
| Removal Correction Number | 2020664-12/02/19-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEALON GV PRO |
| Generic Name | OVDS |
| Product Code | LZP |
| Date Received | 2020-03-03 |
| Model Number | TG85ML |
| Catalog Number | 10270514 |
| Lot Number | UE31283 |
| 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 | 2020-03-03 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |