Class 2 Device Recall Silicone Posterior Chamber Intraocular Lenses

• Date Initiated by Firm: October 31, 2006
• Date Posted: December 14, 2006
• Recall Status: Terminated on January 13, 2012
• Recall Number: Z-0267-2007
• Recall Event ID: 36905
• PMA Number: P880081
• Product Classification: Intraocular Lens - Product Code HQL
• Product: AMO PhacoFlex Il Model SI40NB Intraocular Lenses
• Code Information: Serial Numbers: 1114110408, 1119570408, 1142040205, 1143100207, 1147320306, 1147330306, 1157290307, 1159120306, 1200580409, 1200700409, 1215800307, 1245260307, 1251300402, 1269240205, 1312400308, 1320420307, 1322770202, 1339940208, 1346040309, 1376660402, 1403090305, 1519560303, 1519570303, 1537150408, 1544970308, 1545920407, 1552190306, 1644880406, 1649280409, 1701830307, 1718970304, 1736210308, 1771500312, 1793030407, 1794700312, 1812750311, 1850350301, 1852450310, 1868930404, 1869430308, 1891830306 & 1897480311. All lenses are clearly identified with a 10 digit serial number. The format of the serial number is described below: Example of serial number format for lens: 1230010212 The first digit denotes the particular manufacturing plant within the AMO facility at Anasco, Puerto Rico, where the product was manufactured. The first digit codes are: - 1 or 2: Silicone Plant - 3: Silicone Rework Plant - 4 or 5: Acrylic Plant - 6: Acrylic Rework Plant Digits two through six denote the sequence of numbers assigned to the lenses. The seven and eighth digit denote the year of manufacture. The ninth and tenth digit denote the month of manufacture. In the serial number example above, the serial number represents the 23001 lens produced in the Silicone plant in December 2002.
• Recalling Firm/ Manufacturer: Advanced Medical Optics, Inc.; 1700 E Saint Andrew Pl; Santa Ana CA 92705-4933
• For Additional Information Contact: John Smith; 714-247-8691
• Manufacturer Reason for Recall: These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.
• FDA Determined Cause: Other
• Action: On October 31, 2006, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped. This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility. AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses. AMO will provide updates to the FDA, including all information regarding the recall effectiveness and test results obtained as part of our continuing investigation, as part of the recall progress reports.
• Quantity in Commerce: 55
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = HQL and Original Applicant = Johnson & Johnson Surgical Vision, Inc.