Health product recall

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