ClearanceBrief
Recall Z-1461-2008 ยท HNR Forceps, Ophthalmic

Alcon Research, Ltd

Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.

DateMay 14, 2008 (initiated Mar 7, 2008)
StatusTerminated
ReasonDevice corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.
Root causeDevice Design
ActionConsignees were notified by an Urgent Medical Device Recall that was sent via fax on 03/07/08. Users were instructed to cease using the affected products and to return a Recall Acknowledgement Form to the recalling firm. The sales representative will pick up the affected product and discuss replacement alternatives. For additional information, contact 1-800-757-9780.
Quantity24 units
DistributionNationwide Distribution including states of AL and CA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.