Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile

FDA device recall Z-0530-2015 · posted 2014-12-12 · Terminated

Recall details

Recalling firm

Abbott Medical Optics Inc (AMO)

Reason for recall

AMO has received complaints where the finger grip dislodged while depressing the syringe plunger. The finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye.

Action taken

Abbott Medical Optics issued an Urgent Advisory Notice dated November 4, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to consult the DFU that is distributed with each device, which contains important warning and precautions for use of the product. Customers were instructed to provide a copy of the Advisory Notice to surgeons and thsoe who need to be aware in their organization. Custommers with questions were instructed to call 877-266-4543. For questions regarding this recall call 714-247-8656.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

LZP

Quantity affected

484,881 Nationwide (U.S. and Puerto Rico) and 483,984 Internationally

Distribution

Worldwide Distribution - USA (Nationwide and Puerto Rico) and internationally to the following countries; Italy, Austria, Saudi Arabia, Turkey, Hong Kong, Canada, Germany, Australia, Columbia, Venezue

Date initiated

2014-11-06

Date posted

2014-12-12

Date terminated

2015-05-19

Location

Santa Ana, CA