Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900)

FDA device recall Z-0094-06 · posted 2005-10-28 · Terminated

Recall details

Recalling firm

Advanced Medical Optics, Inc.

Reason for recall

A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.

Action taken

A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.

Root cause

Other

Status

Terminated

Product code

HQL

Quantity affected

7 (none in US)

Distribution

Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam

Date initiated

2005-10-05

Date posted

2005-10-28

Date terminated

2008-05-23

Location

Santa Ana, CA