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January 1, 2005

Misleading Information Given on Product Use—Reply

Author Affiliations

Copyright 2005 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2005

Arch Ophthalmol. 2005;123(1):126-127. doi:10.1001/archopht.123.1.126-c

In reply

In response to Pacer Technology’s plea, we would like to bring attention to a few important facts. As has been the case since the first reported accidental usage of cyanoacrylate as a temporary tarsorrhaphy1 and since the earliest reported use of cyanoacrylate for lid procedures,2 in addition to many other articles commonly quoted and referenced by ophthalmologists around the world when discussing temporary tarsorrhaphies, our use of cyanoacrylate gel to create a temporary tarsorrhaphy for a patient in need was an off-label, non-Food and Drug Administration–approved use of the product. Our article refers to all highly viscous cyanoacrylate gels, not just that manufactured by Pacer Technology. As always, informed consent, sterile techniques, and proper patient selection are of paramount importance when performing any ophthalmic procedure. We hope more companies, with the capabilities to undergo the rigorous federal approval guidelines, will come forward with clinical research studies, so that all of our patients can benefit from the ever-changing and constantly evolving medical breakthroughs that are occurring daily.