HEALON GV PRO (OVD) (2019-12-02)
- Starting date:
- December 2, 2019
- Posting date:
- January 6, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-71999
Last updated: 2020-01-07
Affected Products
HEALON GV PRO (OVD)
Reason
Johnson & Johnson Surgical Vision is voluntarily recalling all HEALON GV PRO products due to complaints reporting that the HEALON GV PRO may be difficult to remove from the eye, leading to increased post-operative intra-ocular pressure requiring additional intervention. There have also been reports of potential clogging of phacoemulsification equipment tubing, which may lead to delay in the procedure or ocular injury.
Affected products
HEALON GV PRO (OVD)
Lot or serial number
UE31408
UE31439
UE31559
Model or catalog number
HEALON GV PRO
Companies
- Manufacturer
-
Johnson & Johnson Surgical Vision, Inc.
1700 East St., Andrew Place
Santa Ana
92705
California
UNITED STATES